Study of Azacitidine,Venetoclax,and Flumatinib in Newly Diagnosed Ph-positive Acute Leukemia and CML-AP/BP Patients

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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