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

Recruiting now

Conditions studied: Chronic Myeloid Leukemia

In brief

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 facts

Study ID

NCT06390306

Run by

Peking University People's Hospital

People needed

30

Starts

2024-07-01

Expected to finish

2027-12-01

Last updated by the study team

2025-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• concurrent diseases requiring treatment(s) with potential to interact with 3G-TKI;
• diagnosis of other primary malignancies;
• history of allogeneic HSCT;
• extramedullary disease only.

Where it is running

• The First Affiliated Hospital, Zhejiang University School of Medicine — Zhejiang, China (enrolling)
• Beijing Lu Daopei Hospital — Beijing, China (enrolling)
• The First Affiliated Hospital of Nanjing Medical University — Nanjing, China (enrolling)
• The First Affiliated Hospital of Guangxi Medical University — Nanning, China (enrolling)
• Nanyang Central Hospital — Nanyang, China (enrolling)
• Ningbo Medical Center Lihuili Hospital — Ningbo, China (enrolling)
• Xi'an International Medical Center Hospital — Xi'an, China (enrolling)
• Peking university people's hospital — Beijing, Beijing Municipality, China (enrolling)
• Chinese Academy of Medical Sciences & Peking Union Medical College Hospital — Tianjin, 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
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Henan Cancer Hospital — Wuhan, China
• Qilu Hospital of Shandong University — Qilu, China

Full record on ClinicalTrials.gov

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