Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06390306 | Not yet recruiting | Chronic Myeloid Leukemia

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

Information provided by (Responsible Party):

Q Ian Jiang

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).

Condition or disease

Chronic Myeloid Leukemia

Intervention/treatment

Ponatinib

Azacitidine

Venetoclax

Olverembatinib

Detailed Description:

CML-MBP has dismal outcome. Currently, there is no standardized induction treatment approach in CML-MBP. The European LeukemiaNet (ELN) recommendations and NCCN guideline recommended the combination of TKI and chemotherapy in CML-MBP. The previous study revealed that TKI combined with hypomethylating agents had promising efficacy. However, imatinib and second generation TKI are the most widely applied in combination treatment, there is limited data in third generation TKI. Currently, venetoclax in combination with hypomethylating agents such as azacitidine is standard treatment for patients with AML unsuitable for intensive induction chemotherapy. Maiti et al. reported that TKI combined with venetoclax and detectable had promising efficacy in CML-MBP. Therefore, the investigator conducted a study to explore the efficacy and safety of a third generation TKI in combination with azacitidine and Bcl-2 inhibitor in CML-MBP and multi-omics exploratory analysis was performed to identify potential biomarkers correlated with the outcome.

Study Type : Observational
Estimated Enrollment : 30 participants
Official Title : 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
Actual Study Start Date : May 1, 2024
Estimated Primary Completion Date : December 1, 2025
Estimated Study Completion Date : December 1, 2026

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Criteria
Inclusion Criteria
  • 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 Criteria
  • concurrent diseases requiring treatment(s) with potential to interact with 3G-TKI;
  • diagnosis of other primary malignancies;
  • history of allogeneic HSCT;
  • extramedullary disease only.
The Efficacy and Safety of Third-generation TKIs Combined With Azacitidine and Bcl-2 Inhibitor in Patients With CML-MBP

Location Details

Please Choose a site

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

China, Beijing

Peking university people's hospital

Beijing, Beijing, China, 100044