The Efficacy and Safety of Third Generation Tyrosine Kinase Inhibitors Combined With Azacitidine and B-cell Lymphoma-2 Inhibitor in Patients With Myeloid Blast Phase Chronic Myeloid Leukemia

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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.

Locations
Other Locations
China
Beijing Lu Daopei Hospital
RECRUITING
Beijing
Chuiyangliu hospital affiliated to tsinghua university
NOT_YET_RECRUITING
Beijing
Peking university people's hospital
RECRUITING
Beijing
Sichuan Provincial People's Hospital
NOT_YET_RECRUITING
Chengdu
Nanfang Hospital, Southern Medical University
NOT_YET_RECRUITING
Guangdong
The First Affiliated Hospital of Kunming Medical University
NOT_YET_RECRUITING
Kunming
The First Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
The First Affiliated Hospital of Guangxi Medical University
RECRUITING
Nanning
Nanyang Central Hospital
RECRUITING
Nanyang
Ningbo Medical Center Lihuili Hospital
RECRUITING
Ningbo
Qilu Hospital of Shandong University
NOT_YET_RECRUITING
Qilu
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
NOT_YET_RECRUITING
Tianjin
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Henan Cancer Hospital
NOT_YET_RECRUITING
Wuhan
Xi'an International Medical Center Hospital
RECRUITING
Xi'an
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Zhejiang
Contact Information
Primary
Qian Jiang, MD
jiangqian@medmail.com.cn
+861088326006
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 30
Treatments
3G-TKI + AZA + Ven group
Adult CML-MBP
Sponsors
Collaborators: Nanfang Hospital, Southern Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Zhejiang University, Peking Union Medical College, Henan Cancer Hospital, Beijing Chuiyangliu Hospital
Leads: Peking University People's Hospital

This content was sourced from clinicaltrials.gov

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