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Cladribine, Idarubicin, Cytarabine, and Venetoclax for Acute Myeloid Leukemia and Related Cancers

This study is testing a combination of four drugs: cladribine, idarubicin, cytarabine, and venetoclax. These drugs are given through an IV (intravenous, meaning into a vein) and work in different ways to stop cancer cells from growing or spreading. The study is for people aged 18 to 65 who have acute myeloid leukemia (AML), acute biphenotypic leukemia, high-risk myelodysplastic syndrome (MDS), or chronic myeloid leukemia (CML) in the blastic phase. The main goal is to see how many patients have a complete response (meaning the cancer is no longer detectable) within 12 months. The study also looks at overall response, how long responses last, and the safety of the drug combination. The current status of this study is unclear, and it plans to enroll about 508 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a Phase II trial, which typically involves a larger group of people to further evaluate the treatment's effectiveness and safety.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures complete response up to 12 months, which suggests participants will be followed for at least this long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02115295

Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia

Recruiting
PHASE2Ages 18–65InterventionalTreatment
M.D. Anderson Cancer Center
~508 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:CladribineCytarabineGilteritinibIdarubicinLaboratory Biomarker AnalysisMidostaurin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete response (CR) rate
Measured over Up to 12 months

Conditions

Acute Biphenotypic Leukemia
Acute Myeloid Leukemia
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Blasts 10 Percent or More of Bone Marrow Nucleated Cells
Blasts 10 Percent or More of Peripheral Blood White Cells
de Novo Myelodysplastic Syndrome
Myelodysplastic Syndrome
Previously Treated Myelodysplastic Syndrome
Recurrent Acute Myeloid Leukemia
Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Refractory Acute Myeloid Leukemia
Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Secondary Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia

Explore related trials

Acute Biphenotypic LeukemiaAcute Myeloid LeukemiaChronic Myeloid Leukemia, BCR-ABL1 PositiveMyelodysplastic Syndrome

Where it's being run

1 sites across 1 states
Texas1

Study leadership

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

Who to contact

Tapan Kadia
[email protected]
713-792-7305
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 - or \<5 x ULN if related to leukemic involvement)
kidney function (creatinine \< 1.5 x ULN ).
known cardiac ejection fraction of \> or = 45% within the past 6 months 6. ECOG performance status of ≤ 2. 7. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial. 8. 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.

What this trial measures

  • Complete response (CR) rateUp to 12 months

    CR rate will be determined.