Study Complete
Sponsor ID
20120216
Blinatumomab in Adults With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia
Study Details
The primary objective is to evaluate the rate of complete remission/complete remission with partial hematological recovery (CRh*) in adults with relapsed/refractory Philadelphia chromosome positive (Ph+) B-precursor acute lymphoblastic leukemia (ALL) who receive blinatumomab.
Protocol Summary
Primary Outcome Measures
Number of Participants with CR/CRh* within 2 cycles of treatment with blinatumomab
Timeframe: Approximately 12 weeks
Secondary Outcome Measures
Number of Participants with MRD remission within 2 cycles of treatment with blinatumomab
Timeframe: Approximately 12 weeks
Duration of CR or CRh*
Timeframe: Approximately 3 - 4 years
Number of Participants with CR within 2 cycles of treatment with blinatumomab
Timeframe: Approximately 12 weeks
Number of Participants with CRh* rate within 2 cycles of treatment with blinatumomab
Timeframe: Approximately 12 weeks
Number of Participants with CR+CRh*+ Complete Response incomplete (CRi) rate within 2 cycles of treatment with blinatumomab
Timeframe: Approximately 12 weeks
Overall survival
Timeframe: Approximately 3 - 4 years
Number of Participants undergoing Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) and 100-day mortality after alloHSCT
Timeframe: 100 days
Number of Participants with Adverse Events as a Measure of Safety and Tolerability and number of participants withIncidence of adverse events and antibody formation
Timeframe: Approximately 2 - 3 years
Serum concentration of blinatumomab
Timeframe: Approximately 2 - 3 years
Study Documents
Study Synopsis
Available Language(s): English
Locations
Location
Research Site
Nantes Cedex 1, France, 44093
Status
Recruiting
Location
Research Site
Berlin, Germany, 12200
Status
Recruiting
Location
Research Site
Bologna, Italy, 40138
Status
Recruiting
Location
Research Site
Duarte, CA, United States, 91010
Status
Recruiting
Location
Research Site
Toulouse cedex 9, France, 31059
Status
Recruiting
Location
Research Site
Paris Cedex 10, France, 75475
Status
Recruiting
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