Clinical summary
Summary
This study has two parts. Eligible participants will be assigned to one of the two parts.
In Part One (Dose Escalation), cohorts of participants will be treated with escalating doses of targeted therapy (blinatumomab) to determine the maximum tolerated dose. Blinatumomab will be administered as an injection (subcutaneous injection).
In Part Two (Dose Expansion), four cohorts of participants with relapsed or refractory B-cell Acute Lymphoblastic Leukaemia will be enrolled to receive the preliminary recommended phase 2 dose that was determined in Part One (Dose Escalation).Treatment Type
Systemic therapy (chemotherapy, hormone therapy or immunotherapy)Age
18+
More information
Trial Identifiers
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Commercial Sponsor
AMGEN
Scientific Title
A Phase 1/2 Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)