OncRef

Clinical Trial: 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

Lead Sponsor:Institute of Hematology & Blood Diseases Hospital, China
Information Provided By:Institute of Hematology & Blood Diseases Hospital, China
Last Update Posted:2025-08-01

Study Overview

Brief 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.

Official Title

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

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention / Treatment

  • Drug: Vincristine
  • Drug: Daunorubicin
  • Drug: Cyclophosphamide
  • Drug: Pegaspargase
  • Drug: Prednisone
  • Drug: Cytarabine
  • Drug: 6-mercaptopurine
  • Drug: Dexamethasone
  • Drug: Methotrexate
  • Drug: Venetoclax

Other Study ID Numbers

  • IIT2022052

Start Date (Actual)

2022-08-01

Primary Completion Date (Estimated)

2027-12-15

Study Completion Date (Estimated)

2027-12-30

Enrollment (Estimated)

100

Study Type

Interventional

Phase

Phase 2