Phase II Study on the Safety and Effectiveness of Dasatinib and Ropeginterferon for Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT07269470

Provider View

This clinical trial is exploring whether a combination of dasatinib and ropeginterferon can effectively manage chronic myeloid leukemia in its early stages. The study also aims to evaluate the safety of this treatment combination.

Patient Parameters

Program Overview

The purpose of this study is to determine if using dasatinib together with ropeginterferon can help control chronic myeloid leukemia in its chronic phase. Researchers will also study how safe this combination is for patients.

Description

The main goal of this study is to see how many patients achieve a significant reduction in leukemia markers in their blood after 12 months of treatment with dasatinib and ropeginterferon. Researchers will also look at how many patients have no detectable leukemia cells in their blood or a major reduction in leukemia markers after 12 months. They will track the number of patients who maintain a deep response to treatment over two years or more. The study will also evaluate the safety of the treatment and monitor patients' survival without events related to leukemia for up to 10 years after the last patient joins the study.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older.
  • Diagnosed with chronic phase chronic myeloid leukemia (CML) that is positive for specific genetic markers (Ph-positive or BCR::ABL1 positive).
  • May have received limited prior treatments like hydroxyurea or a few doses of certain other medications.
  • Good overall health with a performance status score of 0 to 2.
  • Adequate organ function based on specific blood tests.
  • Willing to sign an informed consent form and follow study procedures.
  • Women and men must agree to use effective birth control during the study and for a period after.
  • Patients with controlled hepatitis B or C, or HIV with undetectable viral load, are eligible.
  • Patients with other cancers that do not interfere with the study are eligible.
  • Patients with heart disease must have a stable condition classified as class II or better.

Exclusion Criteria

  • Have received more than 30 days of certain prior treatments for CML.
  • Have not fully recovered from side effects of previous cancer treatments, except for hair loss.
  • Are taking other experimental drugs.
  • Have allergies to dasatinib, ropeginterferon, or similar drugs.
  • Have severe heart disease classified as class III or IV.
  • Have active autoimmune diseases or uncontrolled psychiatric disorders.
  • Have significant uncontrolled infections or conditions.
  • Are pregnant or breastfeeding, due to potential risks to the baby.

Locations

FACILITYZIPCITYSTATE
The University of Texas M. D. Anderson Cancer Center77030HoustonTexas

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