A Phase 1/2 Study of Blinatumomab in Acute Lymphoblastic Leukaemia
Research type
Research Study
Full 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 and Adolescents with Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B‑ALL) and Minimal Residual Disease Positive (MRD+) B‑ALL
IRAS ID
1012706
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc.
Eudract number
2023-506136-32
Clinicaltrials.gov Identifier
Research summary
This study is testing a new way of giving a medicine called blinatumomab to adolescents and adults who have a type of blood cancer called B-cell precursor acute lymphoblastic leukaemia (B-ALL). B-ALL affects the blood and bone marrow. While many people respond well to treatment, some do not (this is called refractory), some have their cancer return (called relapsed), and others have minimal residual disease (MRD), where a small number of cancer cells remain after treatment and may cause the disease to come back.
Blinatumomab is already used in hospitals and works by helping the body’s immune system find and destroy cancerous B-cells. Currently, it is given as a continuous drip through a vein (intravenous infusion), which can be inconvenient and may cause side effects such as infections from the line. This study will test whether giving the medicine by injection under the skin (subcutaneous injection) is safe, effective, and more convenient.
The study is in two phases and will include people aged 12 years and older who have relapsed, refractory, or MRD-positive B-ALL. The first part (Phase 1) will find the appropriate dose for the later part, and the second part (Phase 2) will assess how well it works. Participants may receive up to five treatment cycles (each lasting about five weeks) and will be followed for up to two years.
The study involves regular clinic visits for injections, blood tests, bone marrow checks, and health assessments. Common side effects of blinatumomab include fever, low blood counts, infections, and neurological symptoms. The research aims to improve how blinatumomab is given and help reduce treatment burden and improve outcomes for people with high-risk B-ALL.REC name
South West - Central Bristol Research Ethics Committee
REC reference
25/SW/0152
Date of REC Opinion
7 Jan 2026
REC opinion
Further Information Unfavourable Opinion