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Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Adult Ph- B-ALL

NCT06387121 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2025-12-17

No results posted yet for this study

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.

Conditions

  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

DRUG

Vincristine

Anti-tumor alkaloids

DRUG

Cyclophosphamide

Alkylating agent

DRUG

Dexamethasone

Glucocorticoids

DRUG

Venetoclax

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

DRUG

Inotuzumab ozogamicin

A humanized monoclonal antibody-drug conjugate targeting CD22

DRUG

Blinatumomab

Bi-specific anti-CD19/CD3 antibodies

DRUG

6-mercaptopurine

Cell cycle-specific antitumor drug

DRUG

Methotrexate

Antifolate antineoplastic drug

DRUG

Cytarabine

Pyrimidine antimetabolites

DRUG

Prednisone

Glucocorticoids

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-02
Primary Completion
2026-12-01
Completion
2028-12-31

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 NCT06387121 on ClinicalTrials.gov