drugset / Trial / NCT05660473

Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia

NCT05660473

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-08-01
Primary completion
2027-12-15
Completion
2027-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Venetoclax Small molecule 400 mg Oral
Background Cyclophosphamide Other / unclassified 1200 mg/m2 Intravenous
Background Cytarabine Small molecule
Background Daunorubicin Small molecule 30 mg/m2 Intravenous
Background Dexamethasone Small molecule
Background MERCAPTOPURINE ANHYDROUS Small molecule
Background Methotrexate Small molecule
Background Pegaspargase Protein / enzyme biologic 2500 unknown Intramuscular
Background Prednisone Other / unclassified 0.5 mg/kg Oral
Background Vincristine Small molecule 1.4 mg/m2 Intravenous