Study on Cladribine, Idarubicin, Cytarabine, and Venetoclax for Treating Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02115295

Provider View

This clinical trial is testing a combination of chemotherapy drugs to see how well they work in treating patients with certain types of blood cancers, including acute myeloid leukemia and high-risk myelodysplastic syndrome.

Patient Parameters

Program Overview

This study is exploring how well a combination of chemotherapy drugs—cladribine, idarubicin, cytarabine, and venetoclax—works in treating patients with acute myeloid leukemia (AML), high-risk myelodysplastic syndrome (MDS), or blastic phase chronic myeloid leukemia (CML). These drugs aim to stop cancer cells from growing by killing them, preventing them from dividing, or stopping them from spreading.

Description

The main goal of this study is to find out how many patients achieve a complete response, meaning no signs of cancer, after receiving the combination of cladribine, idarubicin, and cytarabine. Researchers also want to see how long patients live without the cancer coming back and how long the response lasts. They will also look at the safety and side effects of the treatment.

The study will also explore how different patient characteristics and genetic markers affect the treatment outcome and how the cancer changes during therapy.

Treatment Plan:

  • Induction Phase: Patients will receive cladribine and cytarabine through an IV for 1-2 hours on days 1-5, and idarubicin through an IV for 30-60 minutes on days 1-3. Patients with untreated AML and MDS will also take venetoclax by mouth on days 2-8. Some AML patients may receive additional oral medications, midostaurin or gilteritinib, depending on their specific genetic mutations. This treatment cycle repeats every 28 days for up to 2 cycles unless the disease progresses or side effects become too severe.

  • Consolidation Phase: Patients will receive cladribine and cytarabine through an IV for 1-2 hours on days 1-3, and idarubicin through an IV for 30-60 minutes on days 1-2. Patients with untreated AML and MDS will also take venetoclax by mouth on days 2-8. Some AML patients may continue with midostaurin or gilteritinib. This treatment cycle repeats every 28 days for up to 5 cycles unless the disease progresses or side effects become too severe.

After completing the study treatment, patients will have follow-up visits every 6-12 months to monitor their health.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with acute myeloid leukemia (AML), acute biphenotypic leukemia, high-risk myelodysplastic syndrome (MDS), or chronic myeloid leukemia (CML) in blastic phase.
  • For new patients: No previous curative treatment for leukemia, but some prior treatments like hydroxyurea or azacytidine are allowed.
  • For previously treated patients: Must have relapsed or not responded to previous treatments.
  • Age 65 or younger.
  • Adequate liver and kidney function, and a heart ejection fraction of 45% or higher.
  • ECOG performance status of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Negative pregnancy test for women of childbearing potential.
  • Ability to understand the study and provide informed consent.

Exclusion Criteria

  • Pregnant or breastfeeding women due to potential risks to the baby.
  • Uncontrolled illnesses such as active infections, severe heart conditions, or psychiatric issues that could interfere with the study.
  • Allergies to any of the study drugs.
  • Men and women of childbearing potential who do not agree to use contraception during the study.

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