Study on Oral Cladribine for Patients with Acute Myeloid Leukemia (AML)

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07053020

Provider View

This clinical trial is testing the safety and effectiveness of a new oral medication, cladribine, in combination with other drugs for treating patients with Acute Myeloid Leukemia (AML).

Patient Parameters

Program Overview

The study is divided into two parts. Part 1 aims to find the highest safe dose of cladribine that can be given with low dose cytarabine (LDAC) and venetoclax to patients with AML. Part 2 will test if this dose can help control the disease when combined with LDAC and venetoclax.

Description

The main goal of the first phase of this study is to determine how safe and tolerable oral cladribine is for patients with AML and to find the best dose for further testing. The secondary goals include understanding how the body processes cladribine and exploring how well the combination of cladribine, LDAC, and venetoclax works in patients whose AML has returned or not responded to previous treatments.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent before any study procedures.
  • For Part 1: Patients with AML that has returned or not responded to treatment.
  • For Part 2:
    • Cohort A: Patients over 18 with newly diagnosed AML that developed from a previous condition called MDS, after treatment with certain drugs.
    • Cohort B: Patients over 60 with newly diagnosed AML with specific characteristics or mutations, or younger patients unsuitable for standard treatment.
  • Must have good kidney and liver function based on specific lab tests.
  • Must have good heart function with a heart pumping ability of at least 50%.
  • Women of childbearing age must use two forms of birth control during and for 90 days after treatment.
  • Men must agree to use effective contraception during and for 90 days after treatment.

Exclusion Criteria

  • Have uncontrolled illnesses like infections, heart failure, or psychiatric conditions that would interfere with the study.
  • Have allergies to similar medications used in the study.
  • Have legal or mental capacity issues.
  • Cannot swallow pills whole.
  • Are unwilling to follow study requirements.
  • Are pregnant or breastfeeding, due to potential risks to the baby.

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