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

NCT06390306 | Recruiting

• 1 other identifier: 2023PHB323-002
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 15

Brief 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).

Conditions

Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Major hematologic response (MaHR)

  either a complete hematologic response (CHR) or no evidence of leukemia (NEL).

  At the end of Cycle 2 (each cycle is 28 days)

Secondary Outcomes (8)

• Return to chronic phase

  At the end of Cycle 2 (each cycle is 28 days)

• Major cytogenetic response (MCyR)

  Up to 3 years

• Complete cytogenetic response (CCyR)

  Up to 3 years

• Major molecular response (MMR)

  Up to 3 years

• Event-free survival (EFS)

  Up to 3 years

Study Arms (1)

3G-TKI + AZA + Ven group

Adult CML-MBP

Drug: Ponatinib; Drug: Azacitidine; Drug: Venetoclax; Drug: Olverembatinib

Interventions

Ponatinib DRUG

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.

3G-TKI + AZA + Ven group

Azacitidine DRUG

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.

3G-TKI + AZA + Ven group

Venetoclax DRUG

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.

3G-TKI + AZA + Ven group

Olverembatinib DRUG

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.

3G-TKI + AZA + Ven group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Peking universuty people's hospital Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Henan Cancer Hospital The First Affiliated Hospital, Zhejiang University School of Medicine Chinese Academy of Medical Sciences \& Peking Union Medical College Hospital Nanfang Hospital, Southern Medical University Chuiyangliu hospital affiliated to tsinghua university The First Affiliated Hospital of Nanjing Medical University Qilu Hospital of Shandong University Xi'an International Medical Center Hospital Nanyang Central Hospital Ningbo Medical Center Lihuili Hospital Beijing Lu Daopei Hospital Sichuan Provincial People's Hospital The First Affiliated Hospital of Kunming Medical University The First Affiliated Hospital of Guangxi Medical University

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.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Henan Cancer Hospital: collaborator
• Zhejiang University: collaborator
• Peking Union Medical College: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• Beijing Chuiyangliu Hospital: collaborator

Study Sites (15)

Peking university people's hospital

Beijing, Beijing Municipality, 100044, China

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

Biospecimen

Retention: SAMPLES WITH DNA

blood, bone marrow

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

ponatinib; Azacitidine; venetoclax; olverembatinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Qian Jiang, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Jiang, MD

CONTACT

+861088326006; jiangqian@medmail.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 30, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)