Phase 2
N=93
Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT01471782 ↗Enrolled (actual)
93
Serious AEs
58.1%
Results posted
Feb 2017
Primary outcome: Primary: Phase I: Number of Participants With Dose-limiting Toxicities (DLTs) — 0; 1; 2; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Blinatumomab (Biological)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Amgen Research (Munich) GmbH
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase I: Number of Participants With Dose-limiting Toxicities (DLTs) |
0; 1; 2; 1 | — |
| PRIMARY Percentage of Participants With Complete Remission in the First Two Cycles |
20.0; 42.9; 20.0; 33.3; 50.0; 31.8 | — |
| SECONDARY Number of Participants With Adverse Events |
5; 7; 70; 6; 5; 4 | — |
| SECONDARY Steady State Concentration of Blinatumomab |
162; 533; 1520; 456; 866; 1150 | — |
| SECONDARY Time to Hematological Relapse (Duration of Response) |
10.3; 3.4; 5.2 | — |
| SECONDARY Overall Survival |
6.5; 8.2; 7.5 | — |
| SECONDARY Relapse-free Survival |
7.9; 3.4; 4.4 | — |
| SECONDARY Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant During Blinatumomab Induced Remission |
20.0; 28.6; 20.0; 16.7; 30.8; 11.4 | — |
| SECONDARY Number of Participants Who Developed Anti-blinatumomab Antibodies |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Serum Cytokine Peak Levels |
4970; 1780; 23400; 526; 892; 40.4 | — |
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.
Eligibility 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 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 Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT01471782). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.