Brief Title
Study of Azacitidine，Venetoclax，and Flumatinib in Newly Diagnosed Ph-positive Acute Leukemia and CML-AP/BP Patients
Official Title
A Phase Ⅱ, Open Label, Single Arm, Single-Center Study to Evaluate the Efficacy and Safety of Azacitidine，Venetoclax，and Flumatinib in Newly Diagnosed Ph-positive Acute Leukemia and CML-AP/BP Patients
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of
azacitidine，venetoclax，and flumatinib in newly diagnosed Philadelphia chromosome-positive
acute leukemia and accelerated phase or blast phase chronic myeloid leukemia patients.
Detailed Description
This is a phase Ⅱ, open-label, single-arm, single-center study in newly diagnosed Ph-positive
acute leukemia and CML-AP/BP patients. The patients will receive azacitidine, venetoclax, and
flumatinib regimen in the induction treatment. The patients who respond to induction
treatment will undergo consolidation treatment, and an optional allogeneic hematopoietic stem
cell transplantation and post-transplantation maintenance treatment with induction therapy
according to patient's wishes.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
CMR
Secondary Outcome
CR/CRi, MRD-negative CR, CCyR, MMR
Condition
Philadelphia Chromosome
Intervention
Azacitidine
Study Arms / Comparison Groups
Azacitidine，Venetoclax，and Flumatinib Regimen
Description: See Detailed Description.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
30
Start Date
May 1, 2022
Completion Date
June 1, 2025
Primary Completion Date
June 1, 2023
Eligibility Criteria
Inclusion Criteria:
1. Newly diagnosed Ph-positive ALL/AML/MPAL and CML-AP/BP without the history of
chemotherapy or target therapy.
2. Age 18-65.
3. Eastern Cooperative Oncology Group (ECOG) score: 0-3.
4. Total serum bilirubin ≤ 2 x upper limit of normal (ULN), alanine aminotransferase
(ALT) ≤ 1.5 x ULN, aspartate aminotransferase (AST) ≤ 1.5 x ULN.
5. Creatinine clearance ≥ 30 mL/min.
6. Serum lipase ≤ 1.5 x ULN, amylase =< 1.5 x ULN.
7. No consumption of grapefruit, grapefruit products, Seville oranges, or star fruit
within 3 days prior to starting venetoclax.
8. Provide informed consent.
Exclusion Criteria:
1. Patients with another malignant disease.
2. Patients has participated in or participating in other clinical trials.
3. Patients with uncontrolled active infection.
4. Patients with left ventricular ejection fraction < 0.5 by echocardiography or grade
III/IV cardiovascular dysfunction according to the New York Heart Association
Classification.
5. Patients with HIV infection, active tuberculosis infection, or active hepatitis B or
hepatitis C infection.
6. Patients with uncontrolled active bleeding.
7. Patients with history of previous chemotherapy or target therapy (except for oral
hydroxyurea and/or leukopheresis for lowering white blood cell counts).
8. Pregnant and lactating women; patients of childbearing potential should be willing to
practice methods of contraception throughout the study period.
9. Patients with other commodities that the investigators considered not suitable for the
enrollment.
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Xiaowen Tang, Ph.D, 67781525, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT05433532
Organization ID
AZA+VEN+TKI
Responsible Party
Sponsor
Study Sponsor
The First Affiliated Hospital of Soochow University
Study Sponsor
Xiaowen Tang, Ph.D, Study Chair, The First Affiliated Hospital of Soochow University
Verification Date
May 2022