CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 100 target
Drug / intervention
Vincristine +9 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05660473
NCT05660473Phase 2RecruitingOn TrackUpdated 10mo ago
Long Recruiting

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

Institute of Hematology & Blood Diseases Hospital, China·interventional·Posted Dec 21, 2022·Updated Aug 1, 2025

In Brief

A Phase 2 clinical trial evaluating Vincristine, Daunorubicin, and 8 other interventions for Precursor Cell Lymphoblastic Leukemia-Lymphoma. Currently recruiting, targeting 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2Recruiting
202320242025202620272028
First PostedDec 21, 2022
Enrollment StartAug 1, 2022
Primary CompletionDec 15, 2027
Study CompletionDec 30, 2027
TodayJul 1, 2026
Enrollment to primary: 5.4 yearsPosted 3.5 years agoPrimary completion in 1.5 years

Interventions

Vincristinedrug

Anti-tumor alkaloids

Daunorubicindrug

Anthracycline

Cyclophosphamidedrug

Alkylating agent

Pegaspargasedrug

Polyethylene glycol (PEG) conjugated to L-asparaginase

Prednisonedrug

Glucocorticoids

Cytarabinedrug

Pyrimidine antimetabolites

6-mercaptopurinedrug

Cell cycle-specific antitumor drug

Dexamethasonedrug

Glucocorticoids

Methotrexatedrug

Antifolate antineoplastic drug

Venetoclaxdrug

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