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

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Description

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.

Study Overview

Start Date
February 5, 2024
Completion Date
December 31, 2026
Enrollment
124
Date Posted
February 9, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215000, China

Eligibility

Minimum Age (years)
15
Maximum Age (years)
65
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 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

Study Contact Info

Study Contact Name
Jing Lu
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
Yes
FDA Regulated Device?
No
Detailed Description
Blinatumomab, a CD3/CD19 bisespecific T-cell conjugative antibody, has shown high efficacy in phase I/II studies of relapsed/refractory B-lymphoblastic leukemia (B-ALL), particularly in the context of low tumor burden.Meanwhile, Blinatumomab also plays an important role in rapid and efficient clearance of MRD in patients. Therefore, its use in combination with less intensive chemotherapy for initial induction therapy in newly diagnosed patients may result in favorable response rates, greater depth of remission, and lower treatment-related toxic effects.

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.

The regimen of consolidation therapy is recommended as multidrug combination chemotherapy (including high-dose Methotrexate or Cytarabine combined with Asparaginase) or alternating with Blinatumomab (28 ug/d×28d). If Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) is not performed, consolidation therapy needs at least 4 courses before 2 years maintenance therapy.
NCTid (if applicable)
NCT06250959