The Efficacy and Safety of Third-generation TKIs Combined With Azacitidine and Bcl-2 Inhibitor in Patients With CML-MBP
The Efficacy and Safety of Third Generation Tyrosine Kinase Inhibitors Combined With Azacitidine and B-cell Lymphoma-2 Inhibitor in Patients With Myeloid Blast Phase Chronic Myeloid Leukemia
Peking University People's Hospital
30 participants
Jul 1, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria7
- age ≥ 18 years old;
- philadelphia chromosome (Ph)-positive or BCR::ABL-positive;
- serum creatinine ≤ 1.5 × upper limit of normal (ULN) or 24h creatinine clearance ≥ 50 mL/min when serum creatinine was \> 1.5 × ULN;
- serum total bilirubin ≤ 1.5 × ULN;
- aspartate aminotransferase and alanine aminotransferase ≤ 2.5 × ULN;
- amylase ≤ 1.5 × ULN; (7) lipase ≤ 1.5 × ULN;
- ejection fraction \> 50%; corrected QT interval on electrocardiographic evaluation was ≤ 450 ms in men or ≤ 470 ms in women.
Exclusion Criteria4
- concurrent diseases requiring treatment(s) with potential to interact with 3G-TKI;
- diagnosis of other primary malignancies;
- history of allogeneic HSCT;
- extramedullary disease only.
Interventions
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 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 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 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.
Locations(15)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06390306