Phase II Study of Cladribine Plus Low Dose Cytarabine (LDAC) Induction Followed By Consolidation With Cladribine Plus LDAC Alternating With Decitabine in Patients With Untreated Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
Study Drug Administration:
If you are eligible to take part in this study, you will receive 1 or 2 cycles of induction
therapy followed by up to 17 cycles of consolidation therapy. Each study cycle is 4 weeks.
On Days 1-5, you will receive cladribine by vein over 1-2 hours.
On Days 1-10, you will give yourself the cytarabine by injection twice a day about 12 hours
apart. You will receive instructions on how give yourself the injections.
You may receive up to 2 cycles at this dose and schedule.
Consolidation cycles will begin on Cycle 2 regardless of how many cycles you received of
During Cycles 2, 5, 6, 9, 10, 13, 14, 17, and 18:
- On Days 1-3, you will receive cladribine by vein over 1-2 hours.
- On Days 1-10, you will give yourself cytarabine by injection twice daily starting 3 to
6 hours after the start of the cladribine infusion.
Cycles 3, 4, 7, 8, 11, 12, 15, and 16:
-On Days 1-5, you will receive decitabine by vein over 1-2 hours each day.
On Day 1 of every cycle:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
On Day 21 (+/- 7days) of the induction cycle, you may have a bone marrow aspirate to check
the status of the disease. After that, you will have a bone marrow aspirate every 2 weeks
(or more often if your doctor feels it is necessary). If your routine blood tests show that
there is still leukemia, you may not need to have the bone marrow samples collected.
Blood (about 1-2 teaspoons) will be drawn for routine tests at least 1 time weekly until
remission, then every 2-4 weeks during treatment, the every 4-8 weeks while you are on the
Length of Treatment:
You may continue taking the study drugs for up to 18 cycles. You will no longer be able to
take the study drug if the disease gets worse, if intolerable side effects occur, or if you
are unable to follow study directions.
Your participation on the study will be over when you have completed follow-up.
When you are off treatment, every 6 -12 months you will be contacted by a member of the
study staff. You will be asked about any side effects you may be having. The phone calls
will take about 5-10 minutes. You will continue to be called for as long as possible.
This is an investigational study. Cladribine is FDA approved and commercially available for
use in patients with hairy cell leukemia. Its use in patients with AML is investigational.
Cytarabine is FDA approved and commercially available for use in patients with AML.
Decitabine is FDA approved and commercially available for use in patients with MDS. Its use
for patients with AML is investigational.
Up to 160 patients will take part in this study. All will be enrolled at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-Free Survival (DFS)
Disease-free survival (DFS) defined as the time interval from treatment start until clinically significant disease progression or death, whichever occurred first. Participants followed for survival every 6 to 12 months after completion of active treatment. Study continuously monitored for primary endpoint, DFS using the method of Thall, Wooten, and Tannir.
Tapan Kadia, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
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