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NCT Number: NCT05433532

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

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.

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Key information

Conditions

Philadelphia Chromosome Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Bone Marrow Diseases Chromosome Aberrations Chronic Disease Chronic Myeloid Leukemia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Biphenotypic, Acute Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoproliferative Disorders Mixed Phenotype Acute Leukemia Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Translocation, Genetic

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newly diagnosed Ph-positive ALL/AML/MPAL and CML-AP/BP without the history of chemotherapy or target therapy.
  • Age 18-65.
  • Eastern Cooperative Oncology Group (ECOG) score: 0-3.
  • Total serum bilirubin ≤ 2 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 1.5 x ULN, aspartate aminotransferase (AST) ≤ 1.5 x ULN.
  • Creatinine clearance ≥ 30 mL/min.
  • Serum lipase ≤ 1.5 x ULN, amylase =< 1.5 x ULN.
  • No consumption of grapefruit, grapefruit products, Seville oranges, or star fruit within 3 days prior to starting venetoclax.
  • Provide informed consent.

Exclusion criteria

  • Patients with another malignant disease.
  • Patients has participated in or participating in other clinical trials.
  • Patients with uncontrolled active infection.
  • Patients with left ventricular ejection fraction < 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
  • Patients with HIV infection, active tuberculosis infection, or active hepatitis B or hepatitis C infection.
  • Patients with uncontrolled active bleeding.
  • Patients with history of previous chemotherapy or target therapy (except for oral hydroxyurea and/or leukopheresis for lowering white blood cell counts).
  • Pregnant and lactating women; patients of childbearing potential should be willing to practice methods of contraception throughout the study period.
  • Patients with other commodities that the investigators considered not suitable for the enrollment.

Treatment and study plan

Azacitidine

Drug

Azacitidine: 75mg/m2 qd, d1-d7, subcutaneous injection

Venetoclax

Drug

Venetoclax: 100mg d1, 200mg d2, 300mg d3, 400mg d4-d14 or 21, oral (Adjusted according to the peripheral blood BCR/ABL1 results on day 14)

Flumatinib

Drug

Flumatinib: 600mg qd, d4-d21, oral

Primary outcomes

  1. CMR

    Time frame: End of cycle 2 (each cycle is 28 days)

    Complete molecular remission (CMR) was defined as undetectable BCR/ABL transcript.

Secondary outcomes

  1. CR/CRi, MRD-negative CR, CCyR, MMR

    Time frame: End of cycle 1 and 2 (each cycle is 28 days)

    Complete remission (CR) was defined as < 5% bone marrow blasts in an aspirate with spicules and independent of transfusions.

    CR with incomplete hematologic recovery (CRi) was defined as <5% bone marrow blasts, either ANC<1×10^9/L or platelets < 100×10^9/L, transfusion independence but with persistence of cytopenia.

    Minimal residual disease (MRD)-negative CR was defined as a leukemic cell count below the sensitivity threshold of 1×10-4 (0.01%) bone marrow mononuclear cells (MNCs) by multiparameter flow cytometry.

    Complete cytogenetic response (CCyR) was defined as lack of Ph in ≥ 20 bone marrow metaphases.

    Major molecular response (MMR) was defined as a BCR-ABL/ABL transcript ratio of 0.1% (international scale).

  2. Number of adverse events

    Time frame: End of cycle 1 and 2 (each cycle is 28 days)

    Adverse events are evaluated with CTCAE V5.0.

  3. RFS

    Time frame: 2 years

    Relapse-free survival (RFS) was the duration from the day of CR to leukemia relapse, death, or last follow-up.

  4. OS

    Time frame: 2 years

    Overall survival (OS) was the time from enrollment to death for any reason.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 27, 2022
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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