Iovance_IOV-2001_Ph1_CLL_SLL (Chronic Lymphcytic Leukemia or Small Lymphocytic Leukemia)
What is the Purpose of this Study?
If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:
- Have a physical exam
- Have a heart scan (ECG)
- Have blood draws and give urine samples
- Have bone marrow samples taken
- Have images taken (MRI or CT)
After the screening period, this study is divided into 2 different phases: Phase 1 and Phase 2.
If you join the study during Phase 1, you will:
- Get an intravenous (IV) infusion of the study drug followed by a low dose of IL-2; OR
- Get an infusion of the study drug followed by a high dose of IL-2
If you join the study during Phase 2, you will get an infusion of the study drug followed by whichever dose of IL-2 was found to be most effective from Phase 1. Whether or not you are in Phase 1 or Phase 2 of the study will depend on when you join.
In either phase of the study, you will get 3 daily treatments of cyclophosphamide and fludarabine before you receive the study drug. You will also take Mesna along with the cyclophosphamide and fludarabine to reduce the side effects from chemotherapy.
You will check into the hospital the day before you are scheduled to get the study drug. You can check out 24 hours after you finish the regimen of study drug + IL-2 if your study doctor thinks it is fine for you to go home.
- Have a physical exam
- Have a heart scan (ECG)
- Have blood draws and give urine samples
- Have bone marrow samples taken
- Have images taken (MRI or CT)
After the screening period, this study is divided into 2 different phases: Phase 1 and Phase 2.
If you join the study during Phase 1, you will:
- Get an intravenous (IV) infusion of the study drug followed by a low dose of IL-2; OR
- Get an infusion of the study drug followed by a high dose of IL-2
If you join the study during Phase 2, you will get an infusion of the study drug followed by whichever dose of IL-2 was found to be most effective from Phase 1. Whether or not you are in Phase 1 or Phase 2 of the study will depend on when you join.
In either phase of the study, you will get 3 daily treatments of cyclophosphamide and fludarabine before you receive the study drug. You will also take Mesna along with the cyclophosphamide and fludarabine to reduce the side effects from chemotherapy.
You will check into the hospital the day before you are scheduled to get the study drug. You can check out 24 hours after you finish the regimen of study drug + IL-2 if your study doctor thinks it is fine for you to go home.
What is the Condition Being Studied?
Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Who Can Participate in this Study?
Adults diagnosed with CLL or SLL who:
- Have relapsed from previous treatment; OR
- Did not have an adequate response to standard treatments; OR
- Have not received treatment yet
For more information about who can join this study, please contact the study team at surya.nagesh@duke.edu.
Age Group
Adults
Participating Institutions
What is Involved?
We are doing this study is to find out if an experimental drug called IOV-2001 (the study drug) is a safe and effective treatment for CLL/SLL. The study drug will be combined with cyclophosphamide and fludarabine, which are standard drugs used to treat CLL/SLL. After receiving the study drug, participants will be treated with a medication called interleukin-2 (IL-2, Proleukin).
Study Details
Full Title
A Phase 1/2 Study Evaluating the Safety and Efficacy of IOV-2001 in Patients
with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Principal Investigator
Protocol Number
IRB:
PRO00107340
NCT:
NCT04155710
ClinicalTrials.gov
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