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

Last updated: April 3, 2024
Sponsor: Chen Suning
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Blinatumomab Injection [Blincyto]

Doxorubicin

Clinical Study ID

NCT06250959
BEAT-ALL-2024
  • Ages 15-65
  • All Genders

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 Criteria

Inclusion

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 andglucocorticoids ≦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 mustsign the informed consent form.

Exclusion

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 inappropriatefor inclusion by the investigator
  • Pregnant or breastfeeding patients
  • The study patient was refused enrollment

Study Design

Total Participants: 124
Treatment Group(s): 2
Primary Treatment: Blinatumomab Injection [Blincyto]
Phase: 2
Study Start date:
February 05, 2024
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215000
    China

    Active - Recruiting

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