Clinical Trial Goal
To find out if the combination of cladribine, cytarabine, idarubicin and venetoclax is safe and works well to treat AML, MDS, or CML
You may be able to join this trial if you:
- Are 18 – 65 years of age
- Have one of the following diseases:
- Acute biphenotypic leukemia
- AML
- CML
- MDS that doctors think is high risk
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
There are 2 phases in this trial: induction and consolidation.
During induction, the clinical trial doctors will try to get rid of the cancer cells in your body. You'll get:
During induction, the clinical trial doctors will try to get rid of the cancer cells in your body. You'll get:
- Cladribine – Given by intravenous (IV) infusion 1 time each day for 5 days each month. Each infusion takes 1 – 2 hours.
- Cytarabine – Given by IV infusion 1 time each day for 5 days each month. The dose of cytarabine you'll get depends how old you are. Each infusion takes 1 – 2 hours.
- Gilteritinib or midostaurin - A pill that you take by mouth 1 - 2 times each day for 2 weeks each month. Only patients with cancer cells with FLT3 mutations will get this.
- Idarubicin – Given by IV infusion 1 time each day for 3 days each month. Each infusion takes 30 – 60 minutes.
- Venetoclax - A pill that you take by mouth 1 time each day for the first week of each month. Only patients with AML or MDS that have not yet been treated will get this
You may get up to 2 months of treatment during the induction phase.
During consolidation, you'll get:
- Cladribine – Given 1 time each day for 3 days each month.
- Cytarabine – Given 1 time each day for 5 days each month. The dose of cytarabine you'll get depends on how old you are.
- Gilteritinib or midostaurin - A pill that you take by mouth 1 - 2 times each day for 2 weeks each month. Only patients with cancer cells with FLT3 mutations will get this.
- Idarubicin – Given 1 time each day for 2 days each month.
- Venetoclax - A pill that you take by mouth 1 time each day for the first week of each month. Only patients with AML or MDS that have not yet been treated will get this
You may get up to 5 months of treatment during the consolidation phase.
You’ll have at least 2 bone marrow biopsies. During treatment, you must be seen in the clinical trial center every week for the first month and every month after that.
After you finish the treatment, the clinical trial doctors will check your health by phone for as long as the trial is active.
The Food and Drug Administration (FDA) has approved cladribine, cytarabine, idarubicin and venetoclax to treat some kinds of leukemia but using them together is new and unproven.
Locations
M D Anderson Cancer CenterRECRUITING
Houston, Texas
Tapan M. Kadia, 713-792-7305
Sponsors
collaborator: National Cancer Institute (NCI), lead: M.D. Anderson Cancer Center
