RecruitingPhase 2NCT02115295

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

Phase II Study of Cladribine Plus Idarubicin Plus Cytarabine (ARAC) in Patients With AML, HR MDS, or Myeloid Blast Phase of CML

Sponsor

M.D. Anderson Cancer Center

Enrollment

508 participants

Start Date

May 19, 2014

Study Type

INTERVENTIONAL

Conditions

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

Summary

This phase II trial studies how well cladribine, idarubicin, cytarabine, and venetoclax work in patients with acute myeloid leukemia, high-risk myelodysplastic syndrome, or blastic phase chronic myeloid leukemia. Drugs used in chemotherapy, such as cladribine, idarubicin, cytarabine, and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of four drugs — cladribine, idarubicin, cytarabine, and venetoclax — in people with acute leukemia (including AML) or high-risk pre-leukemia conditions (like high-risk MDS), to see if this combination can achieve remission. **You may be eligible if...** - You are 65 or younger - You have been diagnosed with acute myeloid leukemia (AML), acute biphenotypic leukemia, high-risk myelodysplastic syndrome (MDS), or a related leukemic condition - You are either newly diagnosed (frontline) or have relapsed/refractory disease (salvage) - Your liver, kidneys, and heart function are at acceptable levels - You are well enough to carry out basic daily activities **You may NOT be eligible if...** - You are over 65 years old - You have significant heart, liver, or kidney problems - You are pregnant - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.