Entospletinib & Chemo in Newly Diagnosed NPM1-mutated Acute Myeloid Leukemia
What is the Purpose of this Study?
This study has several periods: a screening period, a study drug regime period, and a follow up period.
If you choose to join this study, you will go through the screening period to find out if you are eligible. During the screening period, you will:
- Have a physical exam
- Have blood draws
- Get tested for Hepatitis B and C
- Have a neurological examination
- Have a heart scan (ECG)
If you are eligible, you will begin the study drug regime period. During this portion of the study, you will:
- Receive 1 or 2 cycles of standard chemotherapy (Cytarabine + Daunorubicin or Idarubicin) through infusion (IV)
- Be assigned to take the study drug or a placebo (inactive substance) by mouth 2 times per day
After 1 or 2 cycles of chemotherapy, you will have a bone marrow exam to see how your cancer is responding to treatment. How many more cycles of chemotherapy you will receive will depend on the results of your bone marrow exam. You will take the study drug or placebo during your chemotherapy cycles and in between cycles.
When study drug treatment and chemotherapy ends, you will then enter the follow up period. The study team will monitor your progress once every month for 3 months and then once every 3 months thereafter.
If you choose to join this study, you will go through the screening period to find out if you are eligible. During the screening period, you will:
- Have a physical exam
- Have blood draws
- Get tested for Hepatitis B and C
- Have a neurological examination
- Have a heart scan (ECG)
If you are eligible, you will begin the study drug regime period. During this portion of the study, you will:
- Receive 1 or 2 cycles of standard chemotherapy (Cytarabine + Daunorubicin or Idarubicin) through infusion (IV)
- Be assigned to take the study drug or a placebo (inactive substance) by mouth 2 times per day
After 1 or 2 cycles of chemotherapy, you will have a bone marrow exam to see how your cancer is responding to treatment. How many more cycles of chemotherapy you will receive will depend on the results of your bone marrow exam. You will take the study drug or placebo during your chemotherapy cycles and in between cycles.
When study drug treatment and chemotherapy ends, you will then enter the follow up period. The study team will monitor your progress once every month for 3 months and then once every 3 months thereafter.
What is the Condition Being Studied?
Newly Diagnosed Nucleophosmin 1-mutated Acute Myeloid Leukemia (AML)
Who Can Participate in this Study?
Adults ages 18-75 who:
- Are diagnosed with previously untreated de novo AML, AML with MDS features, and therapy-related AML
- Are diagnosed with documented NPM1-mutated disease
- Do not have an active HIV or Hepatitis B/C infection
- Do not have isolated myeloid sarcoma or acute promyelocytic leukemia
- Do not have known central nervous system involvement with leukemia
For more information about who can join this study, please contact the study team at 919-660-2077.
Age Group
Adults
Participating Institutions
What is Involved?
We are doing this study to find out the most effective, safe dose of an experimental drug called Entospletinib. We want to know how well this study drug works in people with AML when it is given in combination with chemotherapy versus chemotherapy alone.
Study Details
Full Title
Kronos Bio - A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Entospletinib in Combination With Intensive Induction and Consolidation Chemotherapy in Adults With Newly Diagnosed Nucleophosmin 1-mutated Acute Myeloid Leukemia
Principal Investigator
Protocol Number
IRB:
PRO00108790
NCT:
NCT05020665
ClinicalTrials.gov
View on ClinicalTrials.gov