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RDC-Blinatumomab Versus hyperCVAD for Ph-negative B-ALL.

NCT06250959 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2024-04-04

No results posted yet for this study

Summary

In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and 1:1 randomised into Reduced-intensity chemotherapy followed by Blinatumomab cohort or hyperCVAD cohort as induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated.

Conditions

  • ALL, Adult
  • Philadelphia-Negative ALL

Interventions

DRUG

Blinatumomab Injection [Blincyto]

Reduced-intensity chemotherapy followed by Blinatumomab

DRUG

Doxorubicin

HyperCVAD regimen

Sponsors & Collaborators

  • Chen Suning

    lead OTHER

Principal Investigators

  • Jing Lu, MD · Soochow U

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-05
Primary Completion
2025-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

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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 NCT06250959 on ClinicalTrials.gov