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

NCT06390306 · tracked via the Priya Life Science China tracker

Sponsor

Peking University People's Hospital

Phase

Observational

Started

2024-07-01

Last updated

2025-06-03

Condition(s) studied

Chronic Myeloid Leukemia

Investigational drug(s) / intervention(s)

PonatinibAzacitidineVenetoclaxOlverembatinib

Ponatinib: 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: 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: 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: 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.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Major hematologic response (MaHR) — At the end of Cycle 2 (each cycle is 28 days)
either a complete hematologic response (CHR) or no evidence of leukemia (NEL).

Trial sites (15)

Facility	City	Region	Status
Peking university people's hospital	Beijing	Beijing Municipality	Recruiting
Beijing Lu Daopei Hospital	Beijing	China	Recruiting
Chuiyangliu hospital affiliated to tsinghua university	Beijing	China	Not Yet Recruiting
Sichuan Provincial People's Hospital	Chengdu	China	Not Yet Recruiting
Nanfang Hospital, Southern Medical University	Guangdong	China	Not Yet Recruiting
The First Affiliated Hospital of Kunming Medical University	Kunming	China	Not Yet Recruiting
The First Affiliated Hospital of Nanjing Medical University	Nanjing	China	Recruiting
The First Affiliated Hospital of Guangxi Medical University	Nanning	China	Recruiting
Nanyang Central Hospital	Nanyang	China	Recruiting
Ningbo Medical Center Lihuili Hospital	Ningbo	China	Recruiting
Qilu Hospital of Shandong University	Qilu	China	Not Yet Recruiting
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital	Tianjin	China	Not Yet Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Henan Cancer Hospital	Wuhan	China	Not Yet Recruiting
Xi'an International Medical Center Hospital	Xi'an	China	Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine	Zhejiang	China	Recruiting

On this site

📄 Venclexta (venetoclax) drug profile →

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Other trials for the same condition

Observational Study on Dose Optimization of Olverembatinib in Patients With Chronic Myeloid Leukemia in Chronic or Accelerated Phase Enrolling by invitation

TGRX-678 Chinese Phase II in Chronic Myelogenous Leukemia (CML) Patients Recruiting

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International Chronic Myeloid Leukemia Pediatric Study Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06390306 on ClinicalTrials.gov ↗ ← All trials in China