Third-generation TKI combined with azacitidine and a Bcl-2 inhibitor for CML in myeloid blast phase

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter observational study enrolling adults with Philadelphia chromosome–positive CML in myeloid blast phase to receive a third-generation TKI (for example ponatinib or olverembatinib) combined with azacitidine and a Bcl-2 inhibitor (venetoclax). The protocol will collect data on safety, hematologic and molecular response rates, and survival over predefined follow-up periods. Investigators will perform exploratory multi-omics analyses on patient samples to identify biomarkers associated with response or resistance. Data are collected across several academic medical centers in China under standardized procedures.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking university people's hospital
  Beijing, Beijing Municipality, China Recruiting
• Beijing Lu Daopei Hospital
  Beijing, China 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

Study contacts

• Principal investigator: Qian Jiang, MD — Peking University People's Hospital
• Study coordinator: Qian Jiang, MD
• Email: jiangqian@medmail.com.cn
• Phone: +861088326006

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.