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Study Complete
Sponsor ID
20120299

Historical Data Analysis of Complete Remission in Children With R/R Acute Lymphoblastic Leukemia (ALL)

Sponsor ID
20120299
Clinicaltrials.gov ID
NCT02303522
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

An historical data comparator study for children with relapsed/refactory acute lymphoblastic leukemia (ALL).

Additional Study Details

Phase
Phase 4
Product
blinatumomab
Type
Observational
Masking
N/A
Enrollment
207
Additional Study Details

Protocol Summary

Primary Outcome Measures

Hematological Complete Remission (CR)

Timeframe: Approx. 1 year

Secondary Outcome Measures

Overall survival

Timeframe: Approx. 1 year

Molecular CR

Timeframe: Approx. 1 year

Relapse Free Survival (RFS)

Timeframe: Approx. 1 year

Time to hematological CR

Timeframe: Approx. 1 year

Receipt of HSCT after salvage treatment

Timeframe: Approx. 1 year

Locations

Location
Status
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Location
Research Site
Wien, Austria, 1090
Status
Completed
Location
Research Site
Roma, Italy, 00165
Status
Completed
Location
Research Site
Berlin, Germany, 13353
Status
Completed
Study Info
Age
0 - 17 Years
Condition
  • Leukemia
    • Sex
    All
    Trial Dates
    Dec 2014 - Jan 2015
    Inclusion and Exclusion Criteria
    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