CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 53 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.

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Search/NCT06387121
NCT06387121Phase 2RecruitingOn TrackUpdated 6mo ago

Efficacy and Safety of Low-dose Chemotherapy Combined With Immuno-targeted Drugs in Newly Diagnosed Adult Patients With Ph-negative B-cell Acute Lymphocytic Leukemia: A Prospective, Single-arm Clinical Study

Institute of Hematology & Blood Diseases Hospital, China·interventional·Posted Apr 26, 2024·Updated Dec 17, 2025

In Brief

A Phase 2 clinical trial evaluating Vincristine, Cyclophosphamide, and 8 other interventions for Precursor Cell Lymphoblastic Leukemia-Lymphoma. Currently recruiting, targeting 53 participants across 1 site.

Detailed Summary

In the treatment of Ph-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL) among adult patients, therapeutic outcomes remain suboptimal despite advances in chemotherapy and immunotherapy. A subset of adults with Ph- B-ALL have comorbidities or physiological limitations that preclude the safe administration of intensive regimens. In recent years, tumor immunotherapy has demonstrated promising safety and efficacy profiles in refractory or relapsed Ph- B-ALL across a wide spectrum of adult ages. These findings suggest that broader application of immunotherapy may represent a critical strategy to improve survival in this population. In this study, we propose a regimen that combines immuno-targeted agents with low-intensity chemotherapy for newly diagnosed adult patients with Ph- B-ALL. Our primary objective is to increase the rate of measurable residual disease (MRD)-negative complete remission (CR) following induction therapy, reduce the risk of relapse, and ultimately enhance overall survival.

Study Details

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

Timeline

Phase 2Recruiting
20252026202720282029
First PostedApr 26, 2024
Enrollment StartApr 2, 2024
Primary CompletionDec 1, 2026
Study CompletionDec 31, 2028
TodayJul 1, 2026
Enrollment to primary: 2.7 yearsPosted 2.2 years agoPrimary completion in 5 months

Interventions

Vincristinedrug

Anti-tumor alkaloids

Cyclophosphamidedrug

Alkylating agent

Dexamethasonedrug

Glucocorticoids

Venetoclaxdrug

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

Inotuzumab ozogamicindrug

A humanized monoclonal antibody-drug conjugate targeting CD22

Blinatumomabdrug

Bi-specific anti-CD19/CD3 antibodies

6-mercaptopurinedrug

Cell cycle-specific antitumor drug

Methotrexatedrug

Antifolate antineoplastic drug

Cytarabinedrug

Pyrimidine antimetabolites

Prednisonedrug

Glucocorticoids