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RECRUITING
NCT05660473
PHASE2

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

View on ClinicalTrials.gov

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

DRUG

Vincristine

Anti-tumor alkaloids

DRUG

Daunorubicin

Anthracycline

DRUG

Cyclophosphamide

Alkylating agent

DRUG

Pegaspargase

Polyethylene glycol (PEG) conjugated to L-asparaginase

DRUG

Prednisone

Glucocorticoids

DRUG

Cytarabine

Pyrimidine antimetabolites

DRUG

6-mercaptopurine

Cell cycle-specific antitumor drug

DRUG

Dexamethasone

Glucocorticoids

DRUG

Methotrexate

Antifolate antineoplastic drug

DRUG

Venetoclax

Selective inhibitor of B-cell lymphoma 2 (Bcl-2)

Locations (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, China