NCT05660473

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 14 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2022-08-01
• Primary completion: 2027-12-15
• Completion: 2027-12-30
• First posted: 2022-12-21
• Last updated: 2025-08-01

Locations

1 site across 1 country: China