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

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT06817720

Provider View

This clinical trial is exploring whether the drug olverembatinib can effectively control newly diagnosed chronic myeloid leukemia (CML) in its chronic phase. The study also aims to assess the safety and impact on quality of life for participants.

Patient Parameters

Program Overview

The purpose of this study is to determine if olverembatinib can help manage chronic myeloid leukemia (CML) in patients who have been newly diagnosed and are in the chronic phase of the disease. Researchers will evaluate how well the drug works by measuring specific responses in the body over time, such as the reduction of certain cancer markers and overall survival rates. The study will also monitor any side effects and how the treatment affects participants' quality of life.

Description

This study has several goals:

  • Primary Goal: To see how many patients achieve a major molecular response (MMR) within 12 months of starting treatment.
  • Secondary Goals: To measure the complete cytogenetic response (CCyR) rate within 12 months and to estimate the proportion of patients who achieve a deep reduction in cancer markers (MR4.5) at various time points up to 36 months. The study will also look at how long patients live without events related to the disease and overall survival. Additionally, researchers will assess the safety of olverembatinib and its impact on participants' health-related quality of life.

Eligibility Criteria

Exclusion Criteria

  • Have received more than 30 days of previous treatment with FDA-approved tyrosine kinase inhibitors (TKIs) or more than 2 doses of cytarabine.
  • Have had chemotherapy or radiotherapy within 4 weeks before joining the study.
  • Have not fully recovered from side effects of previous cancer treatments, except for hair loss.
  • Are taking other experimental drugs.
  • Have a history of allergic reactions to similar drugs as olverembatinib.
  • Have severe heart disease or symptoms, such as uncontrolled chest pain or certain heart rhythm problems.
  • Have a history of significant bleeding disorders not related to cancer.
  • Have active, uncontrolled psychiatric disorders or cognitive impairments that would affect participation.
  • Have uncontrolled infections or chronic hepatitis B or C with detectable virus load.
  • Are pregnant or breastfeeding, due to potential risks to the baby.
  • Are in the late chronic phase, accelerated phase, or blast phase of CML, as defined by specific medical criteria.

Locations

FACILITYZIPCITYSTATE
MD Anderson Cancer Center77030HoustonTexas

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