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AMG107: Blinatumomab for Acute Lymphoblastic Leukemia

About this study

The blood cancer B-cell acute lymphoblastic leukemia (B-ALL) does not always respond to treatment (refractory). Sometimes it comes back after treatment (relapse). And sometimes a small number of cancer cells are still in the body after treatment. This is called minimal residual disease, or MRD.

Doctors want to find better ways to help children with relapsed, refractory, or MRD-positive disease live longer and stay healthier.

This study tests a medicine called blinatumomab. It is given as a shot under the skin instead of through a vein. This is a type of immunotherapy, which means the medicine helps the body’s immune system find and kill cancer cells. This medicine has helped some patients when given through the vein. Researchers want to see if giving it as a shot under the skin is safe and works well in children.

This study has 2 parts. The first part looks at safety and finds the right dose. The second part looks at how well the medicine works at that dose. Doctors will watch patients closely for side effects and for signs that the cancer gets better or stays away.

Patients in this study may get up to 5 treatment cycles. Each cycle lasts about 5 weeks. It includes days of treatment and days of rest. During the first cycle, patients stay in the hospital so doctors can watch them closely. In later cycles, most visits happen in the clinic. Doctors will do blood tests, bone marrow tests, and other exams to check for side effects and to see if the treatment is working.

Researchers will also study how the medicine moves through the body and how the immune system responds. Children will be followed for up to 2 years after treatment to check their long-term health.

The goal of this study is to learn if blinatumomab given under the skin is safe and helps children with hard-to-treat B-ALL. This may help doctors decide if this new way of giving the medicine should be used more in the future.

Eligibility overview

  • B‑cell precursor acute lymphoblastic leukemia that is relapsed, refractory, or minimal residual disease–positive
  • Age 28 days to younger than 12 years
  • Adequate organ function and ability to receive study treatment

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The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

Overview

Full title:

AMG107: A Phase 1b/2 Study to Investigate the Safety, Efficacy and Pharmacokinetics of Administration of Subcutaneous Blinatumomab in Pediatric Participants with Relapsed/Refractory and Minimal Residual Disease Positive BCell Precursor Acute Lymphoblastic Leukemia

Study goal:

To study subcutaneous blinatumomab in children with relapsed, refractory, or minimal residual disease–positive Bcell acute lymphoblastic leukemia to understand safety, dosing, and how well the treatment works.

Diagnosis:

Bcell acute lymphoblastic leukemia

Age:

28 days through 11 years

Clinical trial categories:

Childhood Cancer Acute Lymphoblastic Leukemia (ALL)

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

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