RecruitingPhase 2NCT06250959

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

Comparing the Efficacy and Safety of Reduced-dose Chemotherapy Followed by Blinatumomab Versus hyperCVAD as Induction Therapy for Newly Diagnosed Ph-negative B-ALL: a Multicenter, Radomized, Phase 2 Study

Sponsor

Chen Suning

Enrollment

124 participants

Start Date

Feb 5, 2024

Study Type

INTERVENTIONAL

Conditions

Philadelphia-Negative ALL ALL, Adult

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.

Eligibility

Min Age: 15 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatment approaches for newly diagnosed Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia (B-ALL), a type of blood cancer. It tests whether a new combination called RDC-Blinatumomab (which includes an immune-activating antibody) works better than the standard intensive chemotherapy regimen called hyperCVAD. **You may be eligible if...** - You are between 15 and 65 years old - You have been newly diagnosed with Ph-negative (BCR-ABL1 negative) B-ALL - You have not yet received induction chemotherapy (short steroid or hydroxyurea use is okay) - Your liver and kidney function meet required levels - You are willing to participate and sign consent **You may NOT be eligible if...** - You have Ph+ (BCR-ABL1 positive) ALL or T-cell ALL - You have mature B-cell leukemia or lymphoma - You have had prior induction chemotherapy - You have central nervous system involvement by leukemia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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