Protocol

ALL1121: A Single-Arm Multicenter Phase II Study preceded by Dose Evaluation to Investigate the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab (MT103) in Pediatric and Adolescent Patients with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia

Diseases

Leukemias / Lymphomas : Relapsed or refractory B-precursor acute lymphoblastic leukemia

Description

This research is focused on patients who have acute lymphocytic leukemia (ALL) that has come back after treatment (relapsed) or did not respond to treatment (refractory). There are about 4,000 new cases of ALL in the United States each year. It appears most often in children younger than age 10. ALL is the most common leukemia in children. Acute lymphoblastic leukemia (ALL) is a fast-growing cancer of the white blood cells. Lymphocytes are a type of white blood cell that the body uses to fight infections. In ALL, the bone marrow makes lots of unformed cells called blasts that normally would develop into lymphocytes. However, the blasts are abnormal. They do not develop and cannot fight infections. The number of abnormal cells (or leukemia cells) grows quickly. They crowd out the normal red blood cells, white blood cells and platelets the body needs.

This is a research study of MT103 (blinatumomab, or study drug) for the treatment of Acute Lymphoblastic Leukemia (ALL) in children and adolescents. The study drug is experimental, which means that this drug has not yet been approved by any authority that regulates new medicines, including the United States (US) Food and Drug Administration (FDA).

This study has two phases. Phase I is tested for different doses of study drug in two age groups (two to six years and seven to 18 years of age) to find the recommended dose for children and adolescents in these age groups. Phase II of the study will test the dose selected in the Phase I part of the study in these same age groups.  Children less than 2 years of age will also be included in the Phase II of the study (not included in Phase I).

Objectives

In phase II of this research study, the main objectives are:

• To find out if blinatumomab will be effective at treating relapsed or refractory ALL at the dose that was selected during phase I of the study.
• To learn more about the side effects of the study drug.

Eligibility

• A patient will be eligible for the study if they are ≤ 18 years at enrollment (only children age 2-18 will be enrolled prior to the identification of the recommended Phase II dose)
• A patient will not be eligible to participate in this study if they have seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder
• A patient will not be eligible for the study if they have known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive) or pregnant or nursing female adolescent patients

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Contact

Deepa Bhojwani MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-866-2ST-JUDE (1-866-278-5833)
FAX: 901-595-5068

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

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.