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

Sponsor
Peking University People's Hospital
Study ID
NCT06390306
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ponatinib — DRUG
    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.
  • Azacitidine — DRUG
    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.
  • Venetoclax — DRUG
    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.
  • Olverembatinib — DRUG
    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.

Study Details

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).

Key Dates

Start date
Jul 1, 2024
Status verified
May 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2027

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: 3G-TKI + AZA + Ven group
    Adult CML-MBP

Primary Outcome Measure

Major hematologic response (MaHR) [ Time Frame: At the end of Cycle 2 (each cycle is 28 days) ]

Central Contacts

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