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Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Summary
The pediatric-inspired regimen has greatly improved the prognosis of adult patients with with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL), but relapse remains a great challenge. Venetoclax (Ven) is an oral, selective inhibitor of B-cell lymphoma 2 (Bcl-2). Although this drug is currently used primarily for acute myeloid leukemia, in vitro as well as small cohort studies suggest a effect in acute lymphoblastic leukemia. This study proposes to combine pediatric-inspired regimen with venetoclax for the treatment of adult patients with Ph- ALL, aiming to improve the MRD-negative complete remission rate measured by flow cytometry after induction and to reduce relapse, thus further improving patients overall survival.
Key Details
Gender
All
Age Range
14 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2022-08-01
Completion Date
2027-12-30
Last Updated
2025-08-01
Healthy Volunteers
No
Interventions
Vincristine
Anti-tumor alkaloids
Daunorubicin
Anthracycline
Cyclophosphamide
Alkylating agent
Pegaspargase
Polyethylene glycol (PEG) conjugated to L-asparaginase
Prednisone
Glucocorticoids
Cytarabine
Pyrimidine antimetabolites
6-mercaptopurine
Cell cycle-specific antitumor drug
Dexamethasone
Glucocorticoids
Methotrexate
Antifolate antineoplastic drug
Venetoclax
Selective inhibitor of B-cell lymphoma 2 (Bcl-2)
Locations (1)
Institute of Hematology & Blood Diseases Hospital
Tianjin, China