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

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 93
• Participant gender: Both

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) and to assess whether this dose of blinatumomab is effective.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen Research (Munich) GmbH
• Treatments: Antibodies, Bispecific; Blinatumomab
• Last Updated: 2016-07-12

Criteria

Inclusion Criteria:

• 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 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 Criteria:

• Active acute or extensive chronic GvHD

• Immunosuppressive agents to prevent or treat GvHD within 2 weeks prior to blinatumomab treatment

• Evidence for current 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)