Blina SC (acute lymphoblastic leukemia)

Clinical study of the safety and efficacy of subcutaneous administration of the drug blinatumomab in children and adolescents with acute lymphoblastic leukemia.

Recruiting

Who can enter

Children and adolescents with B-cell precursor acute lymphoblastic leukemia (B-ALL) whose disease has returned (relapsed) or did not respond adequately to treatment (refractory), or who still have measurable residual disease (MRD+)
Age: 12 years and older

Goal

The goal of this study is to determine whether the drug blinatumomab can be administered subcutaneously (via an injection under the skin) instead of by infusion. The study will investigate whether this is safe, whether it is well tolerated, and how effective the drug is when administered in this way.

Background

The drug blinatumomab is an antibody, a form of immunotherapy. One side of this antibody binds to a specific protein (CD19) on the surface of leukemia cells, and the other side binds to immune cells (T cells). In this way, blinatumomab enables the body's own T cells to recognize and destroy the leukemia cells.

Blinatumomab has been approved in several countries for the treatment of children and adults with relapsed, refractory, or MRD+ B-ALL. The approved mode of administration is via continuous infusion. This mode of administration is particularly challenging in resource poor parts of the world, which may limit access to this drug. In addition, a central line (a small tube placed in a large blood vessel) is often required, which carries the risk of infection.

It is simpler, more convenient, and less expensive to administer blinatumomab via injection under the skin (subcutaneously). This also eliminates the need for a central line, potentially reducing the risk of infection. This has already been studied in people with non-Hodgkin lymphoma (another type of blood cancer). Subcutaneous administration of blinatumomab was well tolerated by these patients and resulted in less severe side effects.

In this study (also known as a clinical trial), blinatumomab is administered subcutaneously to children (>12 years) and adults with relapsed, refractory, or MRD+ B-ALL. Participants receive two to five courses of blinatumomab. In the first week of the first course, they receive a daily injection, and thereafter and for all subsequent courses, they receive three injections per week. Each course lasts four weeks, with a one-week break between courses. The injections are administered in the hospital. The participants are monitored regularly, including through blood or bone marrow tests. The participants will be followed for up to two years.

This is an international study being conducted at more than 40 research sites worldwide. In the Netherlands, the study is being conducted at the Princess Máxima Center.

In order to participate in a study please refer to your/your child’s doctor.

For international patients: please feel welcome to contact our International Patients Office.

Last reviewed

April 16, 2026

Study details
Official 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

Cancer type
B-cell precursor acute lymphoblastic leukemia

Phase
1/2

Maximum number of participants
281 (children and adults), of whom 2 are expected to participate in the Netherlands.

Start date
April 16, 2026

Status
Open

Local principal investigator
Dr. E. Brivio

Sponsor
Amgen

Approval
The study of this new treatment has been reviewed by an accredited medical research ethics committee. This committee has decided that it is justified to ask patients to participate in this study. More information can be found at: CCMO

Trial registry number
EU clinical trials: 2023-506136-32
ClinialTrials.gov: NCT04521231