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

NCT05433532 | Completed Phase 2

• 1 other identifier: AZA+VEN+TKI
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Philadelphia Chromosome; Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Chronic Myeloid Leukemia; Mixed Phenotype Acute Leukemia

Keywords

Ph-positive AL; CML-AP/BP; Azacitidine+Venetoclax+Flumatinib

Outcome Measures

Primary Outcomes (1)

• CMR

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

  End of cycle 2 (each cycle is 28 days)

Secondary Outcomes (4)

• CR/CRi, MRD-negative CR, CCyR, MMR

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

• Number of adverse events

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

• RFS

  2 years

• OS

  2 years

Study Arms (1)

Azacitidine，Venetoclax，and Flumatinib Regimen

EXPERIMENTAL

See Detailed Description.

Drug: Azacitidine; Drug: Venetoclax; Drug: Flumatinib

Interventions

Azacitidine DRUG

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

Azacitidine，Venetoclax，and Flumatinib Regimen

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)

Azacitidine，Venetoclax，and Flumatinib Regimen

Flumatinib DRUG

Flumatinib: 600mg qd, d4-d21, oral

Azacitidine，Venetoclax，and Flumatinib Regimen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Conditions

Philadelphia Chromosome; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Biphenotypic, Acute

Interventions

Azacitidine; venetoclax; flumatinib

Condition Hierarchy (Ancestors)

Translocation, Genetic; Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Xiaowen Tang, Ph.D

  The First Affiliated Hospital of Soochow University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 27, 2022
• Study Start: May 1, 2022
• Primary Completion: April 13, 2024
• Study Completion: April 13, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)