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Cladribine, Cytarabine, and Decitabine for AML or High-Risk MDS

This study is looking at a combination of three drugs – cladribine, cytarabine, and decitabine – for people aged 60 and older with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). The goal is to see if this combination can help control the disease and to understand its safety. Cladribine, cytarabine, and decitabine all work by interfering with the DNA of cancer cells to stop them from growing and repairing themselves. We are hoping to learn how long people stay free from their disease (Disease-Free Survival) after treatment. The study plans to enroll 160 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It is not specified if it's randomized or blinded, and the phase is not specified.
What's involved
You would receive cladribine and decitabine through a vein, and give yourself cytarabine injections twice daily. Treatment could last for up to 18 cycles, with each cycle being 4 weeks long.
Compensation
Not stated in the trial record.
Follow-up
Your participation will end after you complete follow-up, with Disease-Free Survival measured at Day 21.

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NCT01515527

Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)

Recruiting
PHASE2Ages 60+InterventionalTreatment
M.D. Anderson Cancer Center
~160 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:CladribineCytarabineDecitabine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease-Free Survival (DFS)
Measured over Day 21

Conditions

Leukemia

Explore related trials

Acute Myeloid LeukemiaMyelodysplastic Syndrome

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Tapan Kadia, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Tapan Kadia, MD
[email protected]
713-563-3534
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

liver function (bilirubin \< 2mg/dL, AST and/or ALT \<3 x ULN)
kidney function (creatinine \< 1.5 x ULN ). 4. ECOG performance status of ≤ 2. 5. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial. 6. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient is required prior to their enrollment on the protocol. 7. Prior therapy with decitabine will be allowed unless the patient experienced progression to AML while being treated with decitabine.
Creatinine \>/= 2 mg/dL
Total bilirubin \>/= 2 mg/dL
ECOG Performance Status equal to 3 or 4
Is ineligible for participation in a protocol of higher priority 11. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.
liver function (bilirubin \< 2mg/dL, AST and/or ALT \<3 x ULN)
kidney function (creatinine \< 1.5 x ULN ). 4. ECOG performance status of ≤ 2. 5. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial. 6. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient is required prior to their enrollment on the protocol. 7. Prior therapy with venetoclax will be allowed.

What this trial measures

  • Disease-Free Survival (DFS)Day 21

    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.