Study on Cladribine, Idarubicin, Cytarabine, and Quizartinib for Treating Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04047641

Provider View

This clinical trial is testing a combination of four drugs to see if they can effectively treat patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) that is newly diagnosed, has returned, or is not responding to treatment.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a combination of four drugs—cladribine, idarubicin, cytarabine, and quizartinib—in treating patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). These conditions are either newly diagnosed, have come back after treatment, or have not responded to previous treatments. The study aims to see if this drug combination can stop the growth of cancer cells and improve patient outcomes.

Description

This study is divided into three phases: Induction, Consolidation, and Maintenance.

Induction Phase:

  • Patients will receive idarubicin through an IV for 1 hour on days 1-3, cladribine through an IV for 1-2 hours on days 1-5, cytarabine through an IV for 2 hours on days 1-5 (or days 1-3 for patients over 60), and quizartinib orally once a day on days 6-19. This treatment cycle repeats every 28 days for up to 2 cycles, as long as the disease does not progress and side effects are manageable.

Consolidation Phase:

  • Patients who achieve a complete response or a complete response with incomplete platelet recovery after the Induction phase will receive idarubicin through an IV for 1 hour on days 1-2, cladribine through an IV for 1-2 hours on days 1-3, cytarabine through an IV for 2 hours on days 1-3, and quizartinib orally once a day on days 4-28. This treatment cycle repeats every 28 days for up to 5 cycles, as long as the disease does not progress and side effects are manageable.

Maintenance Phase:

  • Patients who achieve a complete response or a complete response with partial recovery after the Consolidation phase will receive quizartinib orally once a day on days 1-28. This treatment cycle repeats every 28 days for up to 12 cycles, as long as the disease does not progress and side effects are manageable.

After completing the study treatment, patients will have follow-up visits every 6-12 months to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with:
    • Acute Myeloid Leukemia (AML) with at least 20% blasts, excluding a specific type called Acute Promyelocytic Leukemia.
    • Acute biphenotypic leukemia.
    • High-risk Myelodysplastic Syndrome (MDS) with more than 10% bone marrow blasts.
  • For newly diagnosed patients (Frontline cohort):
    • Aged 18 to 65 years.
    • Have not received chemotherapy for AML or MDS, except for certain temporary treatments.
  • For relapsed patients (Relapse cohort):
    • Aged 18 years or older.
    • Previously treated, relapsed, or refractory AML, acute biphenotypic leukemia, or high-risk MDS.
  • ECOG performance status of 0 to 2, indicating good overall health.
  • Adequate kidney and liver function as indicated by specific blood tests.
  • Ability to take oral medication.
  • Ability to understand and sign informed consent.
  • Heart function with an ejection fraction of at least 50%.
  • Women of childbearing potential must have a negative pregnancy test and use effective contraception during the study and for 30 days after the last dose. Men must agree to use a condom if their partner is of childbearing potential.
  • Patients with isolated extramedullary myeloid neoplasm are eligible.

Exclusion Criteria

  • Any medical condition that may interfere with the study.
  • Breastfeeding women.
  • Current active cancer or remission for less than 6 months, except for certain skin cancers or carcinoma in situ.
  • Active, serious, and uncontrolled infection.
  • Significant gastrointestinal issues that affect the absorption of quizartinib.
  • Active central nervous system leukemia.
  • Known HIV infection or active viral hepatitis.
  • Major surgery within 14 days before starting the study.
  • Impaired heart function, including:
    • Abnormal heart rhythms or conditions affecting heart rate.
    • Recent heart attack or unstable chest pain.
    • Congestive heart failure class III or IV.
    • Recent atrial fibrillation.
    • Family history of long QT syndrome.
  • Taking strong medications that affect the liver enzyme CYP3A4.

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