RDC-Blinatumomab Versus hyperCVAD for Ph-negative B-ALL.
Recruiting
Phase 2Interventional Study
ALL, AdultPhiladelphia-Negative ALL
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
15 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
124 (estimated)
Sponsor
Chen Suning · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
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…
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
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