Blinatumomab and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the main method potentially curing adult B-ALL, but the high treatment-related mortality (NRM) affects overall survival (OS). Autologous stem cell transplantation (auto-HSCT) can significantly reduce NRM but has a higher relapse rate. Studies have confirmed that achieving MRD negativity before Auto-HSCT can effectively reduce post-transplant relapse, achieving similar efficacy to allo-HSCT. The efficacy of blinatumomab in clearing MRD has been confirmed. Therefore, using blinatumomab combined with Auto-HSCT for B-ALL patients se

Trial Details

NCT ID
NCT06507514
Phase
PHASE1
Sponsor
The First Affiliated Hospital of Soochow University
Status
RECRUITING
Cancer Type
Acute Lymphoblastic (ALL) Leukemia
Interventions
  • blinatumomab and auto-HSCT "sandwich " strategy
Locations (sample)
  • Suzhou, Jiangsu, China|31.30408,120.59538

Key Eligibility Criteria

  • subjects with a primary diagnosis of B-ALL who have any of the following: (a) no suitable allogeneic HSCT donor. (b) refusal of allogeneic HSCT.
  • positive expression of CD19 in peripheral blood or bone marrow primary cells detected by flow cytometry.
  • ardiac ultrasound left ventricular ejection fraction ≥ 50%; Creatinine ≤ 1.6 mg/dl; alanine transaminase (ALT) and aspartate aminotransferase (AST)…
  • subjects aged 15-65 years (including 15 and 65 years), regardless of gender.

For full eligibility, visit ClinicalTrials.gov.

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