Status:
COMPLETED
Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
Lead Sponsor:
Amgen Research (Munich) GmbH
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
Childhood acute lymphoblastic leukemia (ALL) is a type of cancer of the blood and bone marrow in which the bone marrow makes too many abnormal immature lymphocytes. Blinatumomab is a bispecific singl...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT01471782
Start Date
January 1 2012
End Date
May 1 2016
Last Update
February 8 2017
Active Locations (30)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital Denver
Aurora, Colorado, United States, 80045
2
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322
3
Washington University
St Louis, Missouri, United States
4
Memorial Sloan Kettering
New York, New York, United States, 10065