Status:
COMPLETED
Historical Data Analysis of Complete Remission in Children With R/R Acute Lymphoblastic Leukemia (ALL)
Lead Sponsor:
Amgen
Conditions:
B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
Eligibility:
All Genders
Up to 17 years
Brief Summary
An historical data comparator study for children with relapsed/refactory acute lymphoblastic leukemia (ALL).
Detailed Description
A retrospective observational study reviewing historical complete remission for pediatric patients who had either relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL)
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Pediatric (age less than 18 years) patients with relapsed or refractory B-cell precursor ALL, specifically those with
- 2nd or later relapse after chemotherapy (with no prior transplantation),
- Relapse after HSCT, or
- Refractory disease
- Had treatment for relapsed or refractory disease between 2005-2012
- Has data available on ALL treatment, including number of salvage treatments, response status after therapies, and HSCT
- Exclusion criteria:
- No CNS involvement at relapse
- No previous treatment with blinatumomab
Exclusion
Key Trial Info
Start Date :
December 9 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 22 2015
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT02303522
Start Date
December 9 2014
End Date
January 22 2015
Last Update
May 6 2020
Active Locations (3)
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1
Research Site
Vienna, Austria, 1090
2
Research Site
Berlin, Germany, 13353
3
Research Site
Roma, Italy, 00165