Study on Cladribine Plus Low Dose Cytarabine and Decitabine for Patients with Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01515527

Provider View

This clinical trial is testing a combination of three drugs—cladribine, low-dose cytarabine, and decitabine—to see if they can help control Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS). The study will also look at the safety of this drug combination.

Patient Parameters

Program Overview

The purpose of this study is to find out if a combination of cladribine, low-dose cytarabine (LDAC), and decitabine can effectively manage Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS). Cladribine and cytarabine work by inserting themselves into the DNA of cancer cells, stopping them from growing. Decitabine damages the DNA of cancer cells, which may lead to their death. While these drugs are approved for other uses, their combination for treating AML and MDS is still being investigated. Up to 160 patients will participate in this study at MD Anderson.

Description

If you join this study, you will receive up to 18 cycles of treatment, each lasting 4 weeks. The treatment is divided into two phases: induction and consolidation.

Induction Phase:

  • For 1 or 2 cycles, you will receive cladribine through an IV for 1-2 hours on Days 1-5.
  • You will inject yourself with cytarabine twice daily on Days 1-10.

Consolidation Phase:

  • Starting from Cycle 2, you will receive cladribine and cytarabine on specific days, alternating with decitabine in other cycles.
  • Cladribine is given on Days 1-3, and cytarabine is injected twice daily on Days 1-10 during certain cycles.
  • Decitabine is given on Days 1-5 during other cycles.

You will continue treatment unless the disease worsens, side effects become intolerable, or you cannot follow the study directions.

Study Visits:

  • On Day 1 of each cycle, you will have a physical exam and your health status will be recorded.
  • You may have a bone marrow test to check the disease status.
  • Blood tests will be done regularly to monitor your health.

Follow-Up Visits:

  • After treatment, you will be contacted every 6-12 months to discuss any side effects.

Eligibility Criteria

Inclusion Criteria

  • Have untreated AML or high-risk MDS with specific conditions.
  • Be 60 years or older, or younger if unsuitable for standard therapy.
  • Have adequate liver and kidney function.
  • Have a performance status score of 2 or less.
  • Women must have a negative pregnancy test before joining.
  • Must understand and agree to the study requirements and sign a consent form.
  • Previous treatment with decitabine is allowed unless it led to AML progression.

Exclusion Criteria

  • Pregnant or breastfeeding women cannot participate.
  • Have uncontrolled illnesses or conditions that would interfere with the study.
  • Have allergies to any study drugs.
  • Men and women of childbearing potential must use contraception during the study.

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