The Efficacy and Safety of Third-generation TKIs Combined With Azacitidine and Bcl-2 Inhibitor in Patients With CML-MBP

NCT06390306 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-06-03

No results posted yet for this study

Summary

This is a prospective multi-center study to investigate efficacy and safety of the third generation tyrosine kinase inhibitors (TKIs) combined with azacitidine and B-cell lymphoma-2 (Bcl-2) inhibitor in patients with myeloid blast phase chronic myeloid leukemia (CML-MBP).

Conditions

  • Chronic Myeloid Leukemia

Interventions

DRUG

Ponatinib

Ponatinib is recommended orally (PO) daily continuously on days 1-28 in 28-day cycle. Treatment repeats every 28 days in the absence of disease progression, unacceptable toxicity or HSCT.

DRUG

Azacitidine

Azacitidine is recommended 75mg/m2 subcutaneously on days 1-7 in 28-day cycle. Treatment repeats every 28 days in the absence of disease progression, unacceptable toxicity or HSCT.

DRUG

Venetoclax

Venetoclax is recommended orally (PO) daily on days 1-14 in 28-day cycle. Treatment repeats every 28 days in the absence of disease progression, unacceptable toxicity or HSCT.

DRUG

Olverembatinib

Olverembatinib is recommended orally (PO) every other day on days 1-28 in 28-day cycle. Treatment repeats every 28 days in the absence of disease progression, unacceptable toxicity or HSCT.

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    collaborator OTHER
  • Henan Cancer Hospital

    collaborator OTHER_GOV
  • Zhejiang University

    collaborator OTHER
  • Peking Union Medical College

    collaborator OTHER
  • Nanfang Hospital, Southern Medical University

    collaborator OTHER
  • Beijing Chuiyangliu Hospital

    collaborator OTHER_GOV
  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • Qian Jiang, MD · Peking University People's Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2026-12-01
Completion
2027-12-01

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06390306 on ClinicalTrials.gov