Hematologic Malignancies and Cellular Therapy Clinical Trials

22 trials identified.

MacroGenics: Ph1 MGD006 Dual Affinity Re-Targeting (DART) for R/R AML (CP-MGD006-01)
Principal Investigator: Erba, Harry
Protocol Number: PRO00057708

Age Group: Adult
Scope: National

Phase: I (Cancer Control)
Disease Site: Myeloid and Monocytic Leukemia

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
Relapsed or Refractory Acute Myeloid Leukemia 
or
Intermediate-2/High Risk Myelodysplastic Syndrome
What is the Purpose of this Study?
We are doing this study to learn if the study drug, MGD006, is safe and will work for people who have AML and/or MDS.  We also want to know the best dose and side effects that may happen when taking the study drug. 
Who Can Participate in the Study?
Adults with  Relapsed or Refractory Acute Myeloid Leukemia or Intermediate-2/High Risk Myelodysplastic Syndrome (MDS) who:
- Have liver and kidney function that is good enough for it to be safe to get the study drug

--- Patients with AML must be unlikely to get better with standard treatment
--- Patients with MDS must have had treatment failure with induction therapy

- Have not received an allogeneic stem cell transplantation
- Have not had previous treatment with radiotherapy, chemotherapy or immunotherapy in the 4 weeks prior to study treatment
- Do not have central nervous system leukemia
- Do not have active uncontrolled infections, including HIV, Hepatitis B or C 
What is Involved?
If you choose to join this study:
- You will have a screening visit that includes a physical exam, ECG test to see how your heart is working, blood work and a urine test

During Treatment:
- You will get the study drug, MGD006 for 28 days through a needle in your arm

Follow up at end of Treatment will include:
- Checking for any side effects, a physical exam, bone marrow aspirate and biopsy, blood work, and urine test
Participating Institutions:
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov

ECOG-ACRIN E4512 for Early Stage Non-Small Cell Lung Cancer
Principal Investigator: Crawford, Jeffrey
Protocol Number: PRO00060199

Age Group: Adult
Scope: National

Phase: III (Cancer Control)
Disease Site: Lung

Contact: DCI Clinical Research Team, Thoracic Oncology
Email:

What is the Condition Being Studied?
Early Stage Non-Small Cell Lung Cancer
What is the Purpose of this Study?
We are doing this study to see if giving the study drug Crizotinib after surgery (or chemotherapy and/or radiation therapy) will help prevent the cancer from returning.
Who Can Participate in the Study?
Adults with non-small cell lung cancer who:
- Have complete surgical resection of their cancer
- Have had no prior treatment with crizotinib
- Are not pregnant or nursing
What is Involved?
If you choose to join this study, you will:
- Be randomized (like the flip of a coin) to get either:
-- Group 1: The study drug crizotinib twice a day for up to 2 years
-- Group 2: Be followed for observation for up to 10 years
- Get CT scans every 6 months if less than 4 years from study entry and then every 12 months for up to 10 years from study entry
Participating Institutions:
  • Duke University Health System : Thoracic Oncology DCI Clinical Research Team
  • Johnston Health (Smithfield) : Thoracic Oncology DCI Clinical Research Team
  • Maria Parham Health (Henderson) : Thoracic Oncology DCI Clinical Research Team
  • Scotland Health Care System (Laurinburg) : Thoracic Oncology DCI Clinical Research Team
  • Southeastern Regional Medical Center (Lumberton) : Thoracic Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Gamida Cell: GC 05.01.020 Ph3 NiCord vs Unmanipulated UCB for Hematological Malignancies
Principal Investigator: Horwitz, Mitchell
Protocol Number: PRO00072499

Age Group: Both
Scope: National

Phase: III (Cancer Control)
Disease Site: Lymphoid Leukemia; Myeloid and Monocytic Leukemia; Other Hematopoietic

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
Acute lymphoblastic leukemia (ALL); Acute myelogenous leukemia (AML); Chronic myelogenous leukemia (CML); Chronic myelomonocytic leukemia (CMMoL); Myelodysplastic Syndrome (MDS); Lymphoma
What is the Purpose of this Study?
We are doing this study to learn whether NiCord transplants are better than transplants with standard, unmanipulated cord blood units (CBU). 
Who Can Participate in the Study?
Patients 12-65 years of age who:
- Have a diagnosis of hematological malignancy
- Are candidates for unrelated cord blood transplantation
- Qualify with HLA-matched UCB units with sufficient pre-cryopreserved total nucleated cell dose and CD34+ cell dose
What is Involved?
If you choose to join the study, you will:
- Go through the following phases: screening, randomization, conditioning, and transplantation/follow-up
- Be randomized (like the flip of a coin) to receive either NiCord® or unmanipulated cord blood transplantation
- Be given medications to support you during study drug administration 
- Receive unmanipulated CBU(s) or NiCord CF or NiCord NF through the central catheter (injection at the vein)
- Have bone marrow biopsies and/or aspirate, as needed
- Have heart and lung function tests while on the study
- CT Scan (or PET-CT) of your abdomen and pelvis, as needed
- Have blood tests to evaluate overall health and genetic testing
- Be in the study for approximately 478 days from the signing of informed consent to the last visit one year following transplantation
- Have the option to participate in a long term follow-up optional sub-study
Participating Institutions:
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov

Syros Pharmaceuticals: SY-1425-201 Ph2 SY-1425 Tamibarotene AML-MDS
Principal Investigator: Rizzieri, David
Protocol Number: PRO00072859

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Myeloid and Monocytic Leukemia

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) 
What is the Purpose of this Study?
We are doing this study to find out if the study drug, SY-1425-201, works in treating AML and MDS in patients with, or with out a certain biomarker in their blood.
Who Can Participate in the Study?
Adults who 
- Have the biomarker Retinoic Acid Receptor Alpha OR Acute Myeloid Leukemia OR Myelodysplastic Syndrome who:
- Have relapsed and/or refractory AML that has failed to achieve a complete or partial response following standard therapy
- Have relapsed and/or refractory higher risk MDS that has failed to achieve a complete or partial response
- Have new diagnosed AML who are unlikely to tolerate standard intensive chemotherapy 
- Have stopped other chemotherapy, radiation therapy, growth factor and other investigational agents at least two weeks before starting study treatment
- Are willing to be tested for the RARA and IRF8 biomarkers
- Do not have an elevated white blood cell count
- Do not have significant heart disease
- Do not have active, uncontrolled infection, HIV, Hepatitis B or C
- Do not have active, uncontrolled central nervous system leukemia
What is Involved?
If you choose to join the study, you will:
- Have a screening visit to make sure it is safe for you to be in the study

During treatment, you will
- Take the study drug, SY-1425-201, by mouth twice a day every day for 28 days

After treatment is finished, you will have follow-up visits that include physical exams and other tests, every three months for up to 2 years.
Participating Institutions:
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov

MSKCC 15-059: Selection of cell donors using KIR and HLA
Principal Investigator: Rizzieri, David
Protocol Number: PRO00084344

Age Group: Adult
Scope: National

Phase: N/A
Disease Site: Myeloid and Monocytic Leukemia

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
Patients with AML who receive a stem cell transplant
What is the Purpose of this Study?
We are doing this study to find out if the risk for relapse (return of a disease or condition) is lower among patients with KIR advantageous donors who receive a stem cell transplant. The results from this study can be used to help patients who receive stem cell transplants in the future.   
Who Can Participate in the Study?
Adults who:  
- Have been diagnosed with acute myelogenous leukemia  
- Are a candidate for stem cell transplant  
- Have an unrelated donor for transplant (you may still consent to participate if you don't know the status of your donor)
What is Involved?
This is an observational study    
- There are no labs or study visits   
- If you choose to participate, you will be asked to sign a consent form allowing Duke to send the study sponsor information from your medical record including survival, disease status, and treatment.
Participating Institutions:
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov

Alliance A041501 (B-Cell Acute Lymphoblastic Leukemia)
Principal Investigator: Crawford, Jeffrey
Protocol Number: PRO00084507

Age Group: Adult
Scope: National

Phase: III (Cancer Control)
Disease Site: Lymphoid Leukemia

Contact: DCI Clinical Research Team, Leukemia - Multiple Myeloma
Email:

What is the Condition Being Studied?
B-Cell Acute Lymphoblastic Leukemia
What is the Purpose of this Study?
We are doing this study to find out if it is better, the same, or worse adding the study drug Inotuzumab to the usual chemotherapy than getting chemotherapy alone.
Who Can Participate in the Study?
Adults with newly diagnosed B-cell acute lymphoblastic leukemia who: 
- Are 18 or less than 40 years of age
- Have had no prior treatment for acute lymphoblastic leukemia except for limited treatment of less than 7 days
- Do not have Down Syndrome
- Are not pregnant or nursing
What is Involved?
If you choose to join this study, you will:

- Be randomized (put into one of two groups by chance like the flip of a coin) and get either:

-- Group 1: The usual series of leukemia treatments divided into five courses of different combinations of chemotherapy drugs. Depending on the type of ALL, radiation may also be given.
 
-- Group 2: The usual chemotherapy drugs for this type of cancer plus the study drug inotuzumab. Inotuzumab will be given through a vein in 3 doses over a 28-day period called a cycle for a total of 2 cycles. Depending on the type of ALL, radiation may also be given. 

- Be involved in the five courses of chemotherapy for about 3 years, 3 months for males and about 2 years and 3 months for females.

- Get a bone marrow aspirate and biopsy prior to beginning the study and at the end of the chemotherapy courses 1, 2, 4, and 5 to monitor your disease, and if your disease progresses.

- Be followed for up to 10 years after completion of treatment.
Participating Institutions:
  • Duke University Health System : Leukemia - Multiple Myeloma DCI Clinical Research Team
View this trial at ClinicalTrials.gov

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients with FLT3/ITD AML
Principal Investigator: Horwitz, Mitchell
Protocol Number: PRO00084711

Age Group: Adult
Scope: National

Phase: III (Cancer Control)
Disease Site: Myeloid and Monocytic Leukemia

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
AML patients with the FLT3/ITD genetic mutation who are eligible for allogeneic transplant
What is the Purpose of this Study?
We are doing this study to learn if it is safe and effective (works well) to treat patients who have FLT3/ITD AML with a study drug called gilteritinib after transplant. We want to know if this drug works better than a placebo to stop the AML from coming back and what kind of side-effects it may cause.
Who Can Participate in the Study?
Adult men and women who are  
- Candidates for allogeneic transplant  
- Have AML with the FLT3 AML genetic mutation in a CR1 following consolidation therapy  
- Have not had a previous allogeneic transplant
What is Involved?
If you join the study, you will  
- Go through a screening process that includes having a bone marrow biopsy (removal of soft tissue in the bone) that must be done at Duke, blood tests, physical exams, and other tests and questionnaires  
- Be randomized (like the flip of a coin) to receive the drug gilteritinib or placebo (a sugar pill) for two years starting 30-90 days after your allogeneic transplant 
--- Neither you nor your study team or doctor will know what you are taking (although they can find out in an emergency)  
- Have bone marrow biopsies between 30-90 days, 3 months, 6 months, 12, months, 18 months, and 24 months after your transplant  
- Complete health quality of life surveys 8 times during the study  
- Have blood tests monthly while on study drug  
- Have ECG during screening and monthly while on study drug  
- Followed for survival for up to 5 years after stopping drug.
Participating Institutions:
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov

INCB 50465-204 for MZL
Principal Investigator: McKinney, Matthew
Protocol Number: PRO00085229

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Lymphoid Leukemia

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
Relapsed or refractory marginal zone lymphoma (MZL)
What is the Purpose of this Study?
We are doing this study to learn how well INCB050465 works in patients with marginal zone lymphoma (MZL) that is relapsed or refractory after at least 1 systemic treatment regimen.
Who Can Participate in the Study?
Adults with marginal zone lymphoma (MZL) that is relapsed or has not responded to treatment and who: 
- Have previously received 1 or more lines of systemic therapy, including at least 1 anti-CD20 antibody
- Have measurable disease at least 1 lesion larger than 1.5 cm as assessed by CT   
- Have not had any prior treatment with idelalisib or other PI3K inhibitor  
- Don't have active graft versus host disease  
- Don't have liver disease, Hepatitis B or C infection or risk of reactivation 
What is Involved?
If you choose to join the study:
- You will have a screening visit that will include questions, physical examination, blood work, bone marrow biopsy, CT scans, and ECGs.   
- Once your eligibility is confirmed you will be randomly assigned (like the flip of a coin) to one of two groups that will get different doses of INCB050465, which will be taken by mouth every day in 8 week cycles. 

Your study doctor will tell you what dose you will receive.  

You will come back to the clinic every 4 weeks to:  
- Get a new package of tablets 
- Have a physical examination 
- Answer questions about your medications and how you are doing,   
- Have ECGs before you receive your dose and 1.5 hrs after your dose  
- Have CT scans (every 8 weeks)   
- Have a bone marrow biopsy (every 8 weeks) to confirm response if the bone marrow biopsy was positive during screening.    
- Follow up at end of treatment, 30-35 days later, and then every 12 weeks.
Participating Institutions:
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov

Incyte INCB 39110-209 Ph2 Itacitinib PMF, PET-MF and PV-MF
Principal Investigator: Arcasoy, Murat
Protocol Number: PRO00086011

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Other Hematopoietic

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
Myelofibrosis
What is the Purpose of this Study?
We are doing this study to learn about the effects of the drug itacitinib taken with ruxolitinib or itacitinib alone.
Who Can Participate in the Study?
Adults who:
- Have a confirmed diagnosis of PMF, PPV-MF, or PET-MF 
- Have a bone marrow biopsy specimen available or willingness to undergo a bone marrow biopsy 
- Have a life expectancy of at least 24 weeks
- Have an ECOG performance status of 0, 1, or 2.
What is Involved?
If you choose to join this study, you will: 
- Get blood tests, MRIs, plasma lab tests as well as spleen/liver assessments
- Have Lipid panel test (measuring how much fat you have in your blood)
- Have multiple discussions about your current and past health
Participating Institutions:
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov

ECOG-ACRIN EA4151 for Mantle Cell Lymphoma
Principal Investigator: Crawford, Jeffrey
Protocol Number: PRO00088210

Age Group: Adult
Scope: National

Phase: III (Cancer Control)
Disease Site: Lymphoid Leukemia

Contact: SOM Clinical Research Team, Hematology -
Phone:

What is the Condition Being Studied?
Mantle cell lymphoma
What is the Purpose of this Study?
We are doing this study to find out whether an autotransplant improves survival in mantle cell lymphoma patients who have achieved an excellent (minimal residual disease-negative) first complete remission (CR).
Who Can Participate in the Study?
Adults from age 18 to 70 years old who have:
- mantle cell lymphoma confirmed by histology
- have achieved a radiologic complete or partial remission
- must not be pregnant or nursing
What is Involved?
If you agree to be in this study you will:
- Have CT (computed tomography) scan of the chest, abdomen, and pelvis
- Have PET (positron emission tomography) scan
- Have a bone marrow aspirate and biopsy
Be randomized (put into one of four groups by chance like a flip of a coin) and receive either:
Group 1 - complete the initial chemotherapy and receive an autotransplant
Group 2 - complete the initial chemotherapy and NOT receive autotransplant
Groups 3 & 4 - complete initial chemotherapy and undergo high-dose chemotherapy and autotransplant, followed by three years of maintenance rituximab.
Participating Institutions:
  • Duke University Health System : Hematology - SOM Clinical Research Team
View this trial at ClinicalTrials.gov

BeiGene: BGB-3111-304 Phase 3 BGB-3111 Untreated CLL/SLL
Principal Investigator: Brander, Danielle
Protocol Number: PRO00089853

Age Group: Adult
Scope: National

Phase: III (Cancer Control)
Disease Site: Lymphoid Leukemia

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
What is the Purpose of this Study?
We are doing this study to compare the effects, good or bad, of the investigational drug BGB-3111 versus a known standard treatment called bendamustine plus rituximab (B+R) on lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Who Can Participate in the Study?
Adults who:
- Have a confirmed diagnosis of CD20-positive CLL or SLL 
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Have a life expectancy greater than or equal to 6 months 
- Have adequate bone marrow and organ function
What is Involved?
If you choose to join this study, you will:
- Have tests, exams and procedures that are part of your standard care and for study purposes
- Complete questionnaires asking you about your general health, well-being, and overall quality-of-life
- Have your blood tested to find out whether you have CLL/SLL that has a mutation (a change) in one of the chromosomes called '17p deletion'
- Complete a drug diary to show when you have taken a study drug dose, or when you have missed a dose for any reason
Participating Institutions:
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov

AbbVie: M16-186 Ph1b Venetoclax and Alvocidib in R/R AML
Principal Investigator: Erba, Harry
Protocol Number: PRO00091269

Age Group: Adult
Scope:

Phase: I
Disease Site: Myeloid and Monocytic Leukemia

Contact: SOM Clinical Research Team, Hematology -
Phone:

What is the Condition Being Studied?
Relapsed or Refractory Acute Myeloid Leukemia (AML)
What is the Purpose of this Study?
We are doing this study to see if the study drugs, Venetoclax and Alvocidib, can be safely combined for use in patients with relapsed/refactory AML.
Who Can Participate in the Study?
Adults who:
- Have a diagnosis of R/R AML
- Do not have central nervous system leukemia
- Do not have severe chronic obstructive pulmonary disease (COPD) with hypoxemia
- Do not have any prior allogeneic stem cell transplant within 6 months of getting the study drug and no requirement for graft versus host therapy
- Do not have a history of taking alvocidib or any other CDK9 inhibitor
- Do not have any known gastrointestinal disorders 
- Do not have an active, uncontrolled infection 
- Do not have a known active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
What is Involved?
If you choose to join this study, you will:
- Have a screening visit to make sure it safe for you to be in this study
- Take Venetoclax once daily by mouth for 28 days and Alvocidib that will be given by iv infusion on day 1, 2 and 3 of all cycles
- Have a follow-up visit that will include follow up exams and other tests every month for 1 year
Participating Institutions:
  • Duke Cancer Center Cary : Hematological Malignancies, Cellular Therapy and ABMT, Hematology - SOM Clinical Research Team
  • Duke Center for Living/Sarah Stedman Nutrition : Hematological Malignancies, Cellular Therapy and ABMT, Hematology - SOM Clinical Research Team
  • Duke Primary Care : Hematological Malignancies, Cellular Therapy and ABMT, Hematology - SOM Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Hematological Malignancies, Cellular Therapy and ABMT, Hematology - SOM Clinical Research Team
  • Duke Raleigh Hospital : Hematological Malignancies, Cellular Therapy and ABMT, Hematology - SOM Clinical Research Team
  • Duke Regional Hospital : Hematological Malignancies, Cellular Therapy and ABMT, Hematology - SOM Clinical Research Team
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT, Hematology - SOM Clinical Research Team
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Hematological Malignancies, Cellular Therapy and ABMT, Hematology - SOM Clinical Research Team
  • Johnston Health (Smithfield) : Hematological Malignancies, Cellular Therapy and ABMT, Hematology - SOM Clinical Research Team
  • Maria Parham Health (Henderson) : Hematological Malignancies, Cellular Therapy and ABMT, Hematology - SOM Clinical Research Team
  • Scotland Health Care System (Laurinburg) : Hematological Malignancies, Cellular Therapy and ABMT, Hematology - SOM Clinical Research Team
  • Southeastern Regional Medical Center (Lumberton) : Hematological Malignancies, Cellular Therapy and ABMT, Hematology - SOM Clinical Research Team
View this trial at ClinicalTrials.gov

MEI: ME-522-001 Ph1 Voruciclib R/R B Cell Malignancies
Principal Investigator: Brander, Danielle
Protocol Number: PRO00091877

Age Group: Adult
Scope:

Phase: I
Disease Site: Myeloid and Monocytic Leukemia

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
B-cell type cancers
What is the Purpose of this Study?
We are doing this study to find out if a drug called Voruciclib is safe and to find out the most helpful dose of the drug for B-cell type cancer.
Who Can Participate in the Study?
Adults who:
- Have a histologically-confirmed diagnosis of FL, MCL, MZL, SLL, CLL, or DLBCL 
- Have a life expectancy greater than 3 months
- Have the presence of measurable disease defined per the 2008 International workshop on CLL guidelines, or by 2014 Lugano criteria for non-Hodgkin lymphoma 
- Have an Eastern Cooperative Oncology Group (ECOG) performance status less than, or equal to 1 
What is Involved?
If you choose to join this study you will:
- Have information about you collected, such as your age, sex, race/ethnicity, and your medical history including assessing symptoms related to your disease
- Get ECGs (3 times in a row) 
- Have blood collected for health assessments and blood chemistry
- Have your ability to perform everyday tasks assessed 
- Have tests preformed, which may include a biopsy (to look at your disease)
Participating Institutions:
  • Duke Cancer Center Cary : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Center for Living/Sarah Stedman Nutrition : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Primary Care : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Private Diagnostic Clinic (PDC) : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Raleigh Hospital : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Regional Hospital : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Hematological Malignancies, Cellular Therapy and ABMT
  • Johnston Health (Smithfield) : Hematological Malignancies, Cellular Therapy and ABMT
  • Maria Parham Health (Henderson) : Hematological Malignancies, Cellular Therapy and ABMT
  • Scotland Health Care System (Laurinburg) : Hematological Malignancies, Cellular Therapy and ABMT
  • Southeastern Regional Medical Center (Lumberton) : Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov

ImmunoGen:0801 Phase1 IMGN632 in R/R CD123+AML/other CD123+HM
Principal Investigator: Erba, Harry
Protocol Number: PRO00092685

Age Group: Adult
Scope: National

Phase: I (Cancer Control)
Disease Site: Myeloid and Monocytic Leukemia

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
CD123-positive Acute Myeloid Leukemia and Other CD123-positive Hematologic Malignancies
What is the Purpose of this Study?
We are doing this study to find out what dose of the study drug IMGN632 is a good idea for patients who have cancer and to learn what effects, good and/or bad, the study drug may have on patients.
Who Can Participate in the Study?
Adult men and women who have:
- First relapse of CD123+ AML
- Relapse of CD123+ ALL
- Relapse of CD123+ "other" hematologic malignancies  
- Relapse of CD123+ BPDCN
What is Involved?
If you choose to join this study, you will:

- Go through a screening process that includes: 
-- Review of medical history
-- Having a bone marrow aspirate (removal of soft tissue in the bone) that must be done at Duke
-- Blood tests
-- Physical exams
-- PET/CT Scans (if needed)
-- ECHO/MUGA scan 
-- Cheek swab (if enrolled on dose expansion) 
-- other tests

- Be in one of the following groups:
--  The first phase of the study which will find out the highest and safe dose of the study drug IMGN632 through infusion at Duke clinic 
OR
-- You will get one of multiple expansion phases

- Have a complete physical exam, vital signs, and performance status
- Have symptom-directed physical exam
- Have blood tests for safety and PK
- Have urine tests
- Have bone marrow aspirate performed as needed
- Have CT/PET scans (if needed)
- Have Skin lesion assessment/biopsy (if needed)
- Have ECG during screening while on study drug
Participating Institutions:
  • Duke Cancer Center Cary : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Center for Living/Sarah Stedman Nutrition : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Primary Care : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Private Diagnostic Clinic (PDC) : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Raleigh Hospital : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Regional Hospital : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Hematological Malignancies, Cellular Therapy and ABMT
  • Johnston Health (Smithfield) : Hematological Malignancies, Cellular Therapy and ABMT
  • Maria Parham Health (Henderson) : Hematological Malignancies, Cellular Therapy and ABMT
  • Scotland Health Care System (Laurinburg) : Hematological Malignancies, Cellular Therapy and ABMT
  • Southeastern Regional Medical Center (Lumberton) : Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov

Daiichi Sankyo DS3201-A-U102 Phase 1 DS-3201b in AML and ALL
Principal Investigator: Erba, Harry
Protocol Number: PRO00100447

Age Group: Adult
Scope: National

Phase: I
Disease Site: Myeloid and Monocytic Leukemia

Contact: SOM Clinical Research Team, Hematology -
Phone:

What is the Condition Being Studied?
Acute Myeloid Leukemia (AML) or Acute Lymphocytic Leukemia (ALL)
What is the Purpose of this Study?
We are doing this study to find out what dosage of the study drug, DS-3201b, will be safe and will work to treat acute leukemia.
Who Can Participate in the Study?
Adults who:
- Have AML that has failed any prior therapy
- Have adequate organ function (kidney, liver)
- Have stopped other therapy at least 2 weeks before starting study treatment
- Do not have central nervous system involvement of leukemia
- Do not have an active cancer under active treatment
- Do not have an uncontrolled infection 
What is Involved?
If you choose to join this study, you will:
- Have a screening visit to make sure it is safe for you to be in this study.
- Take the study drug, DS-3201b, by mouth once a day every day for 28 days
- Have follow-up visits that will include physical exams and other tests for up to 2 years
Participating Institutions:
  • Duke Cancer Center Cary : Hematology - SOM Clinical Research Team
  • Duke Center for Living/Sarah Stedman Nutrition : Hematology - SOM Clinical Research Team
  • Duke Primary Care : Hematology - SOM Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Hematology - SOM Clinical Research Team
  • Duke Raleigh Hospital : Hematology - SOM Clinical Research Team
  • Duke Regional Hospital : Hematology - SOM Clinical Research Team
  • Duke University Health System : Hematology - SOM Clinical Research Team
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Hematology - SOM Clinical Research Team
  • Johnston Health (Smithfield) : Hematology - SOM Clinical Research Team
  • Maria Parham Health (Henderson) : Hematology - SOM Clinical Research Team
  • Scotland Health Care System (Laurinburg) : Hematology - SOM Clinical Research Team
  • Southeastern Regional Medical Center (Lumberton) : Hematology - SOM Clinical Research Team
View this trial at ClinicalTrials.gov

Tolero: TP-0903 Ph 1/2 Previously Treated CLL
Principal Investigator: Brander, Danielle
Protocol Number: PRO00100635

Age Group: Adult
Scope:

Phase: I/II
Disease Site: Lymphoid Leukemia

Contact: Duke Recruitment Innovation Center
Phone: 919.681.5698

What is the Condition Being Studied?
Previously treated CLL/SLL
What is the Purpose of this Study?
We are doing this study to find out the safety of the study drug, TP-0903 at different doses and to find out if there are any effects the drug may have on patients.
Who Can Participate in the Study?
Adults who: 
- Have an Eastern Cooperative Oncology Group (ECOG) performance status 
- Have good organ function
- Have a confirmed diagnoses of CLL/small lymphocytic lymphoma (SLL) requiring therapy 
- Have coagulation status
What is Involved?
If you choose to join this study you will: 
- Take the study drug, TP-0903
- Have tests, exams, and procedures
- Have blood collected
- Give a urine sample
- Have a bone marrow biopsy and aspirate
- Have a positron emission tomography (PET) scan 
Participating Institutions:
  • Duke Cancer Center Cary
  • Duke Center for Living/Sarah Stedman Nutrition
  • Duke Primary Care
  • Duke Private Diagnostic Clinic (PDC)
  • Duke Raleigh Hospital
  • Duke Regional Hospital
  • Duke University Health System
  • Duke Women's Cancer Care Raleigh (Macon Pond)
  • Johnston Health (Smithfield)
  • Maria Parham Health (Henderson)
  • Scotland Health Care System (Laurinburg)
  • Southeastern Regional Medical Center (Lumberton)
View this trial at ClinicalTrials.gov

GlycoMimetics:301 Phase3 GMI-1271 in People with RR AML
Principal Investigator: Erba, Harry
Protocol Number: PRO00100665

Age Group: Adult
Scope:

Phase: III
Disease Site: Myeloid and Monocytic Leukemia

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
Relapsed/Refractory Acute Myeloid Leukemia 
What is the Purpose of this Study?
We are doing this study to learn if the study drug uproleselan (GMI-1271) is helpful when given together with chemotherapy to patients with relapsed/refractory AML, compared to chemotherapy alone. 

We also want to learn if uproleselan is safe when given with chemotherapy with patients that have relapsed/refractory AML
Who Can Participate in the Study?
Adults who:
-Have either primary refractory or relapsed AML (first or second untreated relapse)
What is Involved?
If you join the study, you will:
- Go through a screening process that includes having a bone marrow biopsy (removal of soft tissue in the bone) and aspirate, blood tests, physical exams, and other tests to determine eligibility for the study.
-Be randomized (like the flip of a coin) to receive chemotherapy with either uproleselan or placebo (saline). Neither you nor your study team or doctor will know what you are taking.
-Be hospitalized up to 60 days if you join main part of the study (depend on how long you need to be in the hospital for AML intervention your study doctor prescribes). 
-Receive uproleselan or placebo (saline) directly into your vein (intravenously).
-Have blood tests to check your blood counts and kidney and liver function 
-Have bone marrow exam, as needed to check your disease.
-Have heart scans (ECG)  as needed
-After the End of Study Intervention visit be contacted  every month for 2 years and every three months thereafter indefinitely for survival information.

Participating Institutions:
  • Duke Cancer Center Cary : Hematological Malignancies, Cellular Therapy and ABMT, Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Center for Living/Sarah Stedman Nutrition : Hematological Malignancies, Cellular Therapy and ABMT, Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Primary Care : Hematological Malignancies, Cellular Therapy and ABMT, Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Private Diagnostic Clinic (PDC) : Hematological Malignancies, Cellular Therapy and ABMT, Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Raleigh Hospital : Hematological Malignancies, Cellular Therapy and ABMT, Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Regional Hospital : Hematological Malignancies, Cellular Therapy and ABMT, Hematological Malignancies, Cellular Therapy and ABMT
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT, Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Hematological Malignancies, Cellular Therapy and ABMT, Hematological Malignancies, Cellular Therapy and ABMT
  • Johnston Health (Smithfield) : Hematological Malignancies, Cellular Therapy and ABMT, Hematological Malignancies, Cellular Therapy and ABMT
  • Maria Parham Health (Henderson) : Hematological Malignancies, Cellular Therapy and ABMT, Hematological Malignancies, Cellular Therapy and ABMT
  • Scotland Health Care System (Laurinburg) : Hematological Malignancies, Cellular Therapy and ABMT, Hematological Malignancies, Cellular Therapy and ABMT
  • Southeastern Regional Medical Center (Lumberton) : Hematological Malignancies, Cellular Therapy and ABMT, Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov

Juno: 017004 Phase 1/2 JCAR017 in RR CLL or SLL
Principal Investigator: Brander, Danielle
Protocol Number: PRO00100726

Age Group: Adult
Scope:

Phase: I/II
Disease Site: Lymphoid Leukemia

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
Relapsed/Refractory Chronic Lymphocytic Lymphoma (CLL)/Small Lymphocytic lymphoma (SLL)
What is the Purpose of this Study?
We are doing this study to find out if the study drug JCAR017 is safe and to find out what dose is recommended for patients with relapsed/refractory CLL or SLL.
Who Can Participate in the Study?
Adults who:
- Have high risk R/R CLL or SLL who have failed at least 2 prior treatments, including a Bruton Kinase inhibitor (like Ibrutinib)
- Have standard-risk R/R CLL or SLL who have failed at least 3 prior treatments, including a BTK inhibitor like Ibrutinib
What is Involved?
If you choose to join this study, you will:
- Have a screening visit that will include questions, physical exam, ECG, blood work, CT and PET scans, and a bone marrow biopsy
- Have a procedure called leukapheresis which involves removing blood cells from a vein in your arm.  These blood cells will be sent to a manufacturing site where they will be used to make the cells that will target your cancer cells
- Come to the clinic for 3 days to get chemotherapy to get your body ready for the infusion of manufactured cells
- Be admitted to the hospital and get the manufactured cells as an infusion into a vein in your arm the next day
- Stay in the hospital for 8 days and then you must come to the clinic for 30 days with a caregiver for tests including questions, physical exam, ECG, blood work, CT and PET scans
- Be in the study for 24-26 months with clinic visits at 2, 3, 6, 9, 12, 18, and 24 months 
Participating Institutions:
  • Duke Cancer Center Cary : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Center for Living/Sarah Stedman Nutrition : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Primary Care : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Private Diagnostic Clinic (PDC) : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Raleigh Hospital : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Regional Hospital : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Hematological Malignancies, Cellular Therapy and ABMT
  • Johnston Health (Smithfield) : Hematological Malignancies, Cellular Therapy and ABMT
  • Maria Parham Health (Henderson) : Hematological Malignancies, Cellular Therapy and ABMT
  • Scotland Health Care System (Laurinburg) : Hematological Malignancies, Cellular Therapy and ABMT
  • Southeastern Regional Medical Center (Lumberton) : Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov

Alpha-1 AntiTrypsin (AAT) in GVHD HCT
Principal Investigator: Horwitz, Mitchell
Protocol Number: PRO00100988

Age Group: Both
Scope:

Phase: II/III
Disease Site: Other Hematopoietic

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
Graft-versus-host disease (GVHD)
What is the Purpose of this Study?
We are doing this study to see if study drug called Alpha 1-antitrypsin (AAT) along with the current standard of care (tacrolimus or cyclosporine and methotrexate) can prevent graft versus-host disease (GVHD) better than the standard of care alone in patients getting hematopoietic cell transplant (HCT).
Who Can Participate in the Study?
Adults who are undergoing HCT for hematological malignancies, including leukemia, lymphoma, multiple myeloma, myelodysplastic syndrome and myeloproliferative neoplasms and have Planned myeloablative conditioning regimen.
What is Involved?
If you join choose to join this study, you will:
- Have a screening visit 
- Get procedures to prepare your body for the transplant
- Have a physical exam and vital signs taken every day for the 5 days before you get the transplant and during study visits
- Have blood drawn
- Get a standard GVHD prevention treatment 3 days before you get the transplant
- Get your first dose of the study drug, AAT, the day before the transplant 
- Be given the stem cells on transplant day
- Have study visits
- Be randomized (like the flip of a coin) to get the study drug AAT or Placebo for 8 weeks
Participating Institutions:
  • Duke Cancer Center Cary : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Center for Living/Sarah Stedman Nutrition : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Primary Care : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Private Diagnostic Clinic (PDC) : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Raleigh Hospital : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Regional Hospital : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Hematological Malignancies, Cellular Therapy and ABMT
  • Johnston Health (Smithfield) : Hematological Malignancies, Cellular Therapy and ABMT
  • Maria Parham Health (Henderson) : Hematological Malignancies, Cellular Therapy and ABMT
  • Scotland Health Care System (Laurinburg) : Hematological Malignancies, Cellular Therapy and ABMT
  • Southeastern Regional Medical Center (Lumberton) : Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov

Itacitinib or Placebo with Corticosteroids in cGVHD
Principal Investigator: Horwitz, Mitchell
Protocol Number: PRO00101558

Age Group:
Scope:

Phase: III
Disease Site: Unknown Sites

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
Graft versus- host disease (GVHD) 
What is the Purpose of this Study?
We are doing this study to see if the study drug (itacitinib) will work better than the placebo when used together with corticosteroids for moderate or severe chronic GVHD. 


Who Can Participate in the Study?
Adults who:
- Have GVHD 
- Have underwent allo-HCT from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood)

What is Involved?
If you choose to join this study, you will have:
- A screening visit
- To take the study drug, itacitinib, by mouth
- A physical exam and the doctor will go over any side effects that you may have experienced
- A review of your ability to perform daily activities
- Blood tests
- An ECG/EKG done
- An assessment of your cGVHD symptoms
- To complete Quality of Life questionnaires

Participating Institutions:
  • Duke Cancer Center Cary : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Center for Living/Sarah Stedman Nutrition : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Primary Care : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Private Diagnostic Clinic (PDC) : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Raleigh Hospital : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Regional Hospital : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Hematological Malignancies, Cellular Therapy and ABMT
  • Johnston Health (Smithfield) : Hematological Malignancies, Cellular Therapy and ABMT
  • Maria Parham Health (Henderson) : Hematological Malignancies, Cellular Therapy and ABMT
  • Scotland Health Care System (Laurinburg) : Hematological Malignancies, Cellular Therapy and ABMT
  • Southeastern Regional Medical Center (Lumberton) : Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov

Celgene: FEDR-MF-001 Ph3b Fedratinib with INT/High Risk PMF, post-PV MF, post-ET MF
Principal Investigator: Rein, Lindsay
Protocol Number: PRO00101624

Age Group: Adult
Scope:

Phase: III
Disease Site: Myeloid and Monocytic Leukemia

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
Intermediate or high-risk primary myelofibrosis (PMF), Postpolycythemia Vera Myelofibrosis (post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (post-ET MF)
What is the Purpose of this Study?
We are doing this study to find out how well the study drug, fedratinib, works for treating MF.  
Who Can Participate in the Study?
Adults who: 
- Have a diagnosis of primary myelofibrosis (PMF) according to the 2016 World Health Organization (WHO) 
- Have been treated with ruxolitinib for less than 3 months
What is Involved?
If you choose to join this study, you will: 
- Have laboratory assessments and other procedures done
- Have to take Vitamin B1, if your blood level decreases
- Get the study drug, fedratinib, once a day in 28 day-cycles
Participating Institutions:
  • Duke Cancer Center Cary : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Center for Living/Sarah Stedman Nutrition : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Primary Care : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Private Diagnostic Clinic (PDC) : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Raleigh Hospital : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Regional Hospital : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Hematological Malignancies, Cellular Therapy and ABMT
  • Johnston Health (Smithfield) : Hematological Malignancies, Cellular Therapy and ABMT
  • Maria Parham Health (Henderson) : Hematological Malignancies, Cellular Therapy and ABMT
  • Scotland Health Care System (Laurinburg) : Hematological Malignancies, Cellular Therapy and ABMT
  • Southeastern Regional Medical Center (Lumberton) : Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov

ArQule: ARQ 531-101 Ph1 ARQ 531 R/R Hematologic Malignancies
Principal Investigator: Brander, Danielle
Protocol Number: PRO00101876

Age Group: Adult
Scope:

Phase: I
Disease Site: Lymphoid Leukemia; Non-Hodgkin Lymphoma

Contact: Duke Recruitment Innovation Center
Phone: 919.681.5698

What is the Condition Being Studied?
Relapsed or Refractory Hematologic Malignancies
What is the Purpose of this Study?
We are doing this study to find out what is the best dose of the study drug (ARQ 531) to use in patients with hematologic malignancies.
Who Can Participate in the Study?
Adults who:
- Have good organ function
- Have a platelet count greater than 50,000/microliters
- Have a creatinine clearance of greater than 60 mL/min 
- Have hemoglobin (Hgb) greater than 8.0 g/dL and stable for greater than 1 week
What is Involved?
If you choose to join this study, you will:
- Give samples of your blood 
- Have assessments of your vital signs 
- Give urine samples 
- Get the study drug, ARQ 531, taken by mouth for one week
Participating Institutions:
  • Duke Cancer Center Cary
  • Duke Center for Living/Sarah Stedman Nutrition
  • Duke Primary Care
  • Duke Private Diagnostic Clinic (PDC)
  • Duke Raleigh Hospital
  • Duke Regional Hospital
  • Duke University Health System
  • Duke Women's Cancer Care Raleigh (Macon Pond)
  • Johnston Health (Smithfield)
  • Maria Parham Health (Henderson)
  • Scotland Health Care System (Laurinburg)
  • Southeastern Regional Medical Center (Lumberton)
View this trial at ClinicalTrials.gov