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

NCT05660473 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-08-01

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Principal Investigators

  • Jianxiang Wang, Dr · Institute of Hematology & Blood Diseases Hospital, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05660473 on ClinicalTrials.gov