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Sponsor ID
20130320

Expanded Access Protocol - Blinatumomab in Pediatric & Adolescent Subjects with Relapsed/Refractory B-precursor ALLRIALTO

Sponsor ID
20130320
Clinicaltrials.gov ID
NCT02187354
EUCTIS ID
N/A
EudraCT ID
2014-001700-21
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Study Details

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

Additional Study Details

Phase
Phase 4
Product
blinatumomab
Type
Expanded Access
Masking
N/A
Enrollment
N/A
Additional Study Details

Protocol Summary

Primary Outcome Measures
Not Available
Secondary Outcome Measures
Not Available

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Cincinnati, OH, United States, 45229
Status
Completed
Location
Research Site
Zuerich, Switzerland, 8032
Status
Recruiting
Location
Research Site
Salt Lake City, UT, United States, 84113
Status
Recruiting
Location
Research Site
Wien, Austria, 1090
Status
Recruiting
Location
Research Site
Roma, Italy, 00165
Status
Recruiting
Location
Research Site
Aurora, CO, United States, 80045
Status
Recruiting
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Study Info
Age
0 - 17 Years
Condition
  • Leukemia
    • Sex
    All
    Trial Dates
    N/A - N/A
    Inclusion and Exclusion Criteria
    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