Study on Cladribine and Venetoclax for Treating Monocytic Acute Myeloid Leukemia (AML)

Sponsor: University of Colorado, Denver

Sponsor score: 40

ClinicalTrials ID:NCT06232655

Provider View

This clinical trial is exploring a new treatment using Cladribine and Venetoclax for patients with a specific type of Acute Myeloid Leukemia (AML) that has not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to test the effectiveness of a new treatment combination, Cladribine and Venetoclax, for patients with a type of Acute Myeloid Leukemia (AML) that has a monocytic phenotype and has not responded to previous treatments with hypomethylating agents and Venetoclax. The study will involve cycles of treatment, with the first cycle including Cladribine given through an IV for five days and Venetoclax taken daily for 28 days. A bone marrow biopsy will be done at the end of the first cycle to check the response. If the treatment is effective, patients may continue with alternating cycles of different drug combinations. The study will continue unless the disease progresses, the treatment is not effective, or the patient experiences significant side effects or chooses to stop.

Description

This study is designed to evaluate a new treatment approach for patients with a specific type of Acute Myeloid Leukemia (AML) that has not responded to previous therapies. The treatment involves using Cladribine and Venetoclax. In the first cycle, patients will receive Cladribine through an IV for five days and take Venetoclax daily for 28 days. At the end of this cycle, a bone marrow biopsy will be performed to assess the response. If the treatment is effective, patients may continue with alternating cycles of different drug combinations. The study will continue unless the disease progresses, the treatment is not effective, or the patient experiences significant side effects or chooses to stop.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of Acute Myeloid Leukemia (AML) with a monocytic or monoblastic phenotype or a Ras pathway mutation.
  • The AML must have returned or not responded to previous treatment with hypomethylating agents and Venetoclax.
  • Must be 18 years or older.
  • Must have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Must have adequate kidney and liver function as shown by specific blood tests.
  • Male participants must use contraception and avoid donating sperm during and for 90 days after treatment.
  • Female participants must be postmenopausal, surgically sterile, or use contraception during and for six months after treatment.
  • Must sign an informed consent form to participate.

Exclusion Criteria

  • Have previously been treated with Cladribine for AML.
  • Have a high white blood cell count, unless controlled with medication or procedures.
  • Have active central nervous system involvement of AML.
  • Have an uncontrolled infection requiring treatment.
  • Have significant health conditions that could affect participation, such as severe heart failure or other serious diseases.
  • Have a prolonged QT interval on an ECG.
  • Have had another cancer within the past two years, with some exceptions for certain treated cancers.
  • Are pregnant or breastfeeding.
  • Are known to be HIV positive.
  • Are known to have active hepatitis B or C, unless the viral load is undetectable.

Locations

FACILITYZIPCITYSTATE
Universtiy of Colorado Hospital80045AuroraColorado

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