CML ADVOCATES NETWORK

Clinical Trials

3rd generation TKIs plus Azacitidine and Bcl-2 Inhibitor in CML-MBP [China]

Study title

Efficacy and Safety of 3rd generation TKIs Combined With Azacitidine and Bcl-2 Inhibitor in Patients With CML-MBP

Scientific title

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

Type of study

Observational (Patient Registry)

Current status

Recruiting

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Other trial ID

2023PHB323-002, ClinicalTrials.gov NCT06390306

What is the purpose of the study

This is a study to evaluate third generation tyrosine kinase inhibitors (TKIs) taken in combination with azacitidine and B-cell lymphoma-2 inhibitor as a possible treatment for Chronic Myeloid Leukemia in Myeloid Blast Phase (CML-MBP). The study assesses how effective and safe the medications are when given as combination therapy.

What will happen during the study

All patients will be given ponatinib, venetoclax and olverembatinib orally (by mouth), and azacitidine subcutaneously (as an injection under the skin).

Key inclusion criteria

This study includes patients of all sexes who:

  • are aged at least 18 years
  • philadelphia chromosome (Ph)-positive or BCR::ABL-positive
  • have adequate function of major organs (kidney, liver, heart), as specified in the study protocol

Further criteria apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

This study does not include patients who:

  • have concurrent diseases requiring treatment(s) that could potentially interact with 3rd generation TKI
  • have been diagnosed with other primary malignant diseases
  • have a history of allogeneic hematopoietic stem cell transplantation
  • have leukemic cells outside of the bone marrow (socalled extramedullary disease) only.

Further criteria apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

December 2026

Where can I find additional information

You can find a study description in the US register ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.

Study sponsor

Peking University People’s Hospital in collaboration with

  • Wuhan Union Hospital, China
  • Henan Cancer Hospital
  • Zhejiang University
  • Peking Union Medical College
  • Nanfang Hospital, Southern Medical University
  • Beijing Chuiyangliu Hospital

Scientific lead / contact

Qian Jiang, MD, Peking University People’s Hospital

Principal investigator

Qian Jiang, MD, Peking University People’s Hospital

Study centers / principal investigators

China

Beijing
Bejing, 100044
Peking University People’s Hospital
Principal Investigator: Qian Jiang, MD
Contact: Cuicui Con

Beijing
Beijing  Lu Daopei Hospital
Contact: Qinag Fu

Nanjing
The First Affiliated Hospital of Nanjing Medical University
Contact: Yu Zhu

Nanjing
The First Affiliated Hospital of Guangxi Medical University
Contact: Zhenfang Liu

Ningbo
Ningbo Medical Center Lihuili Hospital
Contact: Jing Le

Xi’an
Xi’an International Medical Center Hospital
Contact: Guohiu Li

Zhejiang
The First Affiliated Hospital, Zhejian University School of Medicine
Contact: Jian Huang