Study Complete
Sponsor ID
20120216

Blinatumomab in Adults With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia

Sponsor ID
20120216
Clinicaltrials.gov ID
NCT02000427
EUCTIS ID
N/A
EudraCT ID
2006-006520-19

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.

Additional Study Details

Phase
Phase 2
Product
blinatumomab
Type
Interventional
Masking
None (Open Label)
Enrollment
45
Additional Study Details

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
Status
Contact Us
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
Showing {first} - {last} of {total} Results