Expanded Access Protocol - Blinatumomab in Pediatric & Adolescent Subjects With Relapsed/Refractory B-precursor ALL
| Status: | No longer available |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any - 17 |
| Updated: | 3/20/2019 |
An Open-Label, Multi-center, Expanded Access Protocol of Blinatumomab for the Treatment of Pediatric and Adolescent Subjects With Relapsed and/or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)
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
second or later bone marrow relapse, in any marrow relapse after alloHSCT, or refractory to
other treatments
Secondary Objective(s):
To describe key efficacy outcomes, including incidence of complete response (CR) within 2
cycles of blinatumomab, minimal residual disease (MRD) remission within 2 cycles of
blinatumomab, relapse free survival (RFS), overall survival (OS), incidence of alloHSCT, and
100-day mortality after alloHSCT.
Hypotheses:
A formal statistical hypothesis will not be tested. The incidence of treatment-emergent and
treatment-related adverse events will be estimated.
Study Endpoints:
- Incidence of treatment-emergent and treatment-related adverse events
- Incidence of CR within 2 cycles of blinatumomab
- MRD remission within 2 cycles of blinatumomab
- RFS
- OS
- Incidence of alloHSCT
- 100-day mortality after alloHSCT
Study Design:
Multi-center, open-label, single-arm expanded access protocol
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
second or later bone marrow relapse, in any marrow relapse after alloHSCT, or refractory to
other treatments
Secondary Objective(s):
To describe key efficacy outcomes, including incidence of complete response (CR) within 2
cycles of blinatumomab, minimal residual disease (MRD) remission within 2 cycles of
blinatumomab, relapse free survival (RFS), overall survival (OS), incidence of alloHSCT, and
100-day mortality after alloHSCT.
Hypotheses:
A formal statistical hypothesis will not be tested. The incidence of treatment-emergent and
treatment-related adverse events will be estimated.
Study Endpoints:
- Incidence of treatment-emergent and treatment-related adverse events
- Incidence of CR within 2 cycles of blinatumomab
- MRD remission within 2 cycles of blinatumomab
- RFS
- OS
- Incidence of alloHSCT
- 100-day mortality after alloHSCT
Study Design:
Multi-center, open-label, single-arm expanded access protocol
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
We found this trial at
5
sites
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