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

Recruiting now · Phase 2

Conditions studied: ALL, Adult, Philadelphia-Negative ALL

In brief

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.

Key facts

Study ID

NCT06250959

Run by

Chen Suning

People needed

124

Starts

2024-02-05

Expected to finish

2026-12-31

Last updated by the study team

2024-04-04

Who can join

Age: 15 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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