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RecruitingNCT06390306

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

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Trial Parameters

ConditionChronic Myeloid Leukemia
SponsorPeking University People's Hospital
Study TypeOBSERVATIONAL
PhaseN/A
Enrollment30
SexALL
Min Age18 Years
Max AgeN/A
Start Date2024-07-01
Completion2026-12-01
Interventions
PonatinibAzacitidineVenetoclax

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Brief 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).

Eligibility Criteria

Inclusion Criteria: 1. age ≥ 18 years old; 2. philadelphia chromosome (Ph)-positive or BCR::ABL-positive; 3. serum creatinine ≤ 1.5 × upper limit of normal (ULN) or 24h creatinine clearance ≥ 50 mL/min when serum creatinine was \> 1.5 × ULN; 4. serum total bilirubin ≤ 1.5 × ULN; 5. aspartate aminotransferase and alanine aminotransferase ≤ 2.5 × ULN; 6. amylase ≤ 1.5 × ULN; (7) lipase ≤ 1.5 × ULN; 7. ejection fraction \> 50%; corrected QT interval on electrocardiographic evaluation was ≤ 450 ms in men or ≤ 470 ms in women. Exclusion Criteria: 1. concurrent diseases requiring treatment(s) with potential to interact with 3G-TKI; 2. diagnosis of other primary malignancies; 3. history of allogeneic HSCT; 4. extramedullary disease only.

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