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A Phase 1/2 Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL) and Minimal Residual Disease Positive (MRD+) B-ALL

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Trial Profile

A Phase 1/2 Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL) and Minimal Residual Disease Positive (MRD+) B-ALL

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 15 Nov 2025

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At a glance

  • Drugs Blinatumomab (Primary)
  • Indications Precursor B-cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Sponsors Amgen

Most Recent Events

  • 03 Nov 2025 Planned primary completion date changed from 24 Dec 2027 to 27 Jul 2027.
  • 27 Aug 2025 Status changed from active, no longer recruiting to recruiting.
  • 06 Aug 2025 Protocol has been amended. Number of arms changed from 3 to 5, Experimental: Ph-IIR: Efficacy of SC Blinatumomab in Participants with R/R B-ALL and Experimental: Ph-IIM: Efficacy of SC Blinatumomab in Participants with MRD+ B-ALL has been added to study protocol. Eligibility age criteria has been changed to 12 Years and older.

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