Status:
NO_LONGER_AVAILABLE
Expanded Access Protocol - Blinatumomab in Pediatric & Adolescent Subjects With Relapsed/Refractory B-precursor ALL
Lead Sponsor:
Amgen
Conditions:
Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia
Eligibility:
All Genders
Up to 17 years
Brief Summary
Primary Objective: To estimate the incidence of treatment-emergent and treatment-related adverse events during treatment with blinatumomab in pediatric and adolescent subjects with B-precursor ALL in...
Eligibility Criteria
Inclusion
- Inclusion Criteria 101 Immunophenotypic evidence of CD19 positive B-precursor ALL (pro B-, pre B-, common ALL) 102 Age \> 28 days and \< 18 years at the time of informed consent/assent 103 Morphological or molecular evidence of relapsed/refractory disease, defined as one of the following:
- Second or later bone marrow relapse (defined as M3 marrow or M2 marrow or M1 marrow but with MRD level ≥ 10E-3), or
- Any marrow relapse after alloHSCT (defined as M3 marrow or M2 marrow or M1 marrow but with and MRD level ≥ 10E-3), or
- Refractory to other treatments:
- For patients in first relapse: failure to achieve a CR following a full standard reinduction chemotherapy regimen
- For patients who have not achieved a first remission: failure to achieve remission following a full standard induction regimen
- Subjects previously treated with blinatumomab may be eligible, if subject ended treatment for reason(s) other than disease progression or intolerability to blinatumomab (Note: This does not include patients who have already received blinatumomab treatment on this study, but refers only to patients outside of the 20130320 study)
- Other Inclusion Criteria may apply
- Exclusion Criteria 201 Any active acute Graft-versus-Host Disease (GvHD) grade 2 to grade 4 according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment 202 Immunosuppresive agents to prevent or treat GvHD within 2 weeks prior to blinatumomab treatment (except for topical corticosteroids) 203 Active (overt) ALL in the CNS (confirmed by cerebrospinal fluid \[CSF\] analysis) or in testes
- Other Exclusion Criteria may apply
Exclusion
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02187354
Last Update
May 13 2024
Active Locations (19)
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1
Research Site
Aurora, Colorado, United States, 80045
2
Research Site
Cincinnati, Ohio, United States, 45229
3
Research Site
Memphis, Tennessee, United States, 38105
4
Research Site
Salt Lake City, Utah, United States, 84113