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Recruiting Phase 2

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

NCT06250959 · tracked via the Priya Life Science China tracker
Sponsor
Chen Suning
Phase
Phase 2
Started
2024-02-05
Last updated
2024-04-04

Condition(s) studied

ALL, AdultPhiladelphia-Negative ALL

Investigational drug(s) / intervention(s)

Blinatumomab Injection [Blincyto] →Doxorubicin →

Blinatumomab Injection [Blincyto]: Reduced-intensity chemotherapy followed by Blinatumomab

Doxorubicin: HyperCVAD regimen

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.

Eligibility

Sex
ALL
Min age
15 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Age 15-65 * Ph-(BCR-ABL1 negative)B-ALL was diagnosed according to WHO diagnostic criteria * Newly diagnosed patients without prior induction therapy (except hydroxyurea and glucocorticoids ≦5 days * ECOG score 0-3 * Liver function: total bilirubin ≦ 3 times the upper limit of normal; Alanine ·aminotransferase ≦ 3 times upper limit of normal motion; Aspartate aminotransferase ≦ 3 times upper limit of normal motion; (except considering leukemia infiltration) * Renal function: endogenous creatinine clearance ≧30ml/min * Patients must be able to understand and willing to participate in the study and must sign the informed consent form. Exclusion Criteria: * Ph+ (BCR-ABL1 positive) ALL * T cells ALL * Mature B-cell leukemia/lymphoma, B-cell lymphoma, with extramedullary disease * Acute mixed-cell leukemia * Central nervous system leukemia * HIV infection * HBV-DNA or HCV-RNA positive * Patients with grade 2 or higher heart failure and other patients deemed inappropriate for inclusion by the investigator * Pregnant or breastfeeding patients * The study patient was refused enrollment

Primary outcome measure(s)

  • Composite complete remission rate — Induction therapy phase: The time of bone marrow evaluation is day 28±7.
    CR/CRi

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Soochow University Suzhou Jiangsu Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06250959 on ClinicalTrials.gov ↗ ← All trials in China