Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in China / NCT06390306
Recruiting Observational

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)

Ponatinib →Azacitidine →Venetoclax →Olverembatinib →

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
No
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)

FacilityCityRegionStatus
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 →

More Peking University People's Hospital trials in China

Longitudinal Cohort of Thrombosis and Hemostasis Diseases Recruiting
Age-Stratified Conditioning Regimen Efficacy for MDS Haplo-HSCT Recruiting
Evaluation of Musculoskeletal Aging and Related Disorders Via Advanced Clinical Imaging Recruiting
Critical Illness After Hematopoietic Cell Transplantation Starting soon
Trilaciclib Combing Chemotherapy in the Neoadjuvant Treatment of Osteosarcoma Recruiting

Other trials for the same condition

A Study of HS-10382 Versus Investigator-selected TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP Starting soon
International Chronic Myeloid Leukemia Pediatric Study Recruiting
TGRX-678 Chinese Phase II in Chronic Myelogenous Leukemia (CML) Patients Recruiting
Observational Study on Dose Optimization of Olverembatinib in Patients With Chronic Myeloid Leukemia in Chronic or Accelerated Phase Enrolling by invitation
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