RecruitingNCT06390306

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

Sponsor

Peking University People's Hospital

Enrollment

30 participants

Start Date

Jul 1, 2024

Study Type

OBSERVATIONAL

Conditions

Chronic Myeloid Leukemia

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — a third-generation TKI (a type of targeted cancer drug), azacitidine (a chemotherapy), and venetoclax (a drug that helps cancer cells die) — in people with a rare and aggressive form of leukemia called CML in myeloid blast phase, which means the leukemia has progressed to an advanced stage. **You may be eligible if...** - You are 18 or older - You have a type of leukemia that is Philadelphia chromosome-positive or BCR-ABL-positive (confirmed by lab tests) - Your liver, kidney, and heart function are within acceptable limits **You may NOT be eligible if...** - You have had a bone marrow or stem cell transplant in the past - You have another type of cancer at the same time - You take medications that could interact with the study drug - Your leukemia is only outside the bone marrow (extramedullary disease only) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPonatinib

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.

DRUGAzacitidine

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.

DRUGVenetoclax

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.

DRUGOlverembatinib

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)

Peking university people's hospital

Beijing, Beijing Municipality, China

Beijing Lu Daopei Hospital

Beijing, China

Chuiyangliu hospital affiliated to tsinghua university

Beijing, China

Sichuan Provincial People's Hospital

Chengdu, China

Nanfang Hospital, Southern Medical University

Guangdong, China

The First Affiliated Hospital of Kunming Medical University

Kunming, China

The First Affiliated Hospital of Nanjing Medical University

Nanjing, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, China

Nanyang Central Hospital

Nanyang, China

Ningbo Medical Center Lihuili Hospital

Ningbo, China

Qilu Hospital of Shandong University

Qilu, China

Chinese Academy of Medical Sciences & Peking Union Medical College Hospital

Tianjin, China

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

Wuhan, China

Xi'an International Medical Center Hospital

Xi'an, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06390306

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