Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

Completed · Phase 1/Phase 2

Conditions studied: Acute Lymphoblastic Leukemia

In brief

The purpose of this study is to determine the dose of the bispecific T cell engager blinatumomab (MT103) in pediatric and adolescent patients with relapsed/refractory acute lymphoblastic leukemia (ALL) and to assess whether this dose of blinatumomab is effective.

Key facts

Study ID

NCT01471782

Run by

Amgen Research (Munich) GmbH

People needed

93

Starts

2012-01-01

Expected to finish

2016-05-01

Last updated by the study team

2017-02-08

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Morphologic evidence of B-precursor ALL with > 25% blasts in bone marrow (M3) at study enrolment
• Age less than 18 years at enrollment
• Relapsed/refractory disease:
• Second or later bone marrow relapse,
• Any marrow relapse after allogeneic hematopoietic stem cell transplantation (HSCT), or
• Refractory to other treatments: Patients in first relapse must have failed to achieve a CR following full standard reinduction chemotherapy regimen of at least 4 weeks duration. Patients who have not achieved a first remission must have failed a full standard induction regimen
• Karnofsky performance status more than or equal to 50% for patients more than or equal to 16 years and Lansky Performance Status (LPS) of more than or equal to 50% for patients less than 16 years
• Organ function requirements: All patients must have adequate renal and liver functions

You may not qualify if…

• Active acute or extensive chronic graft-versus-host disease (GvHD)
• Immunosuppressive agents to prevent or treat GvHD within 2 weeks prior to blinatumomab treatment
• Evidence for current central nervous system (CNS) involvement by ALL (CNS 2, CNS 3) or testicular involvement by ALL
• History of relevant CNS pathology or current relevant CNS pathology
• History of autoimmune disease with potential CNS involvement or current autoimmune disease
• Any HSCT within 3 months prior to blinatumomab treatment
• Cancer chemotherapy within 2 weeks prior to blinatumomab treatment (except for intrathecal chemotherapy and/or low dose maintenance therapy such as vinca alkaloids, mercaptopurine, methotrexate, glucocorticoids)
• Chemotherapy related toxicities that haven't resolved to less than or equal to Grade 2
• Radiotherapy within 2 weeks prior to blinatumomab treatment
• Immunotherapy (e.g. rituximab, alemtuzumab) within 6 weeks prior to blinatumomab treatment
• Any investigational product within 4 weeks prior to study entry
• Previous treatment with blinatumomab
• Active severe infection, any other concurrent disease or medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol
• Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive)

Where it is running

• Children's Hospital Denver — Aurora, Colorado, United States
• Children's Healthcare of Atlanta at Egleston — Atlanta, Georgia, United States
• Washington University — St Louis, Missouri, United States
• Memorial Sloan Kettering — New York, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• St Jude Children's Research Hospital — Memphis, Tennessee, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• Texas Children's Cancer Center/ Baylor — Houston, Texas, United States
• Primary Children's Medical Center — Salt Lake City, Utah, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• St. Anna Kinderspital — Vienna, Austria
• Hospital for Sick Children — Toronto, Ontario, Canada
• (CHU Besancon) Hopital Saint-Jaques — Besançon, France
• Hôpital de la Timone (Enfants) — Marseille, France
• Hopital Robert Debré (AP-HP) — Paris, France
• Charité Campus Virchow Klinikum, Otto-Heubner-Centrum (OHC) für Kinder- und Jugendmedizin — Berlin, Germany
• Universitätsklinikum Düsseldorf — Düsseldorf, Germany
• Universitätsklinikum Essen — Essen, Germany
• Klinikum der Johann Wolfgang Goethe-Universität Frankfurt/Main — Frankfurt am Main, Germany
• Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany
• Medizinische Hochschule Hannover — Hanover, Germany
• Universitätsklinikum Schleswig-Holstein Campus Kiel — Kiel, Germany
• Klinikum der Universität München, Dr. von Haunersches Kinderspital — München, Germany
• Universitätsklinik für Kinder- und Jugendmedizin Tübingen — Tübingen, Germany

Full record on ClinicalTrials.gov

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