An Open-label, Multi-centre, Randomized, Phase Ib Study to Investigate the Safety and Efficacy of RO5072759 Given in Combination With CHOP, FC or Bendamustine Chemotherapy in Patients With CD20+ B-cell Follicular Non-Hodgkin's Lymphoma
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma
Both
Non-Hodgkin's Lymphoma
Trial Information
An Open-label, Multi-centre, Randomized, Phase Ib Study to Investigate the Safety and Efficacy of RO5072759 Given in Combination With CHOP, FC or Bendamustine Chemotherapy in Patients With CD20+ B-cell Follicular Non-Hodgkin's Lymphoma
Inclusion Criteria:
- Adult patients, >18 years of age
- Either CD20+ relapsed or refractory B-cell follicular non-Hodgkin's lymphoma (after a
maximum of 2 prior chemotherapy regimens) or CD20+ B-cell follicular non-Hodgkin's
lymphoma with no prior systemic therapy
- ECOG performance status of 0-2
Exclusion Criteria:
- Prior administration of rituximab within 8 weeks of study entry, or 3 months for any
radioimmunotherapy
- Central nervous lymphoma
- History of other malignancies within 2 years of study entry which could affect
compliance with the protocol or interpretation of results
- Active infection, or any major episode of infection requiring hospitalization or
treatment with iv antibiotics within 4 weeks of dosing
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety: Incidence of adverse events
Outcome Time Frame:
up to 6 years
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
France:AFSSAPS
Study ID:
BO21000
NCT ID:
NCT00825149
Start Date:
February 2009
Completion Date:
October 2015
Related Keywords:
- Non-Hodgkin's Lymphoma
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, Non-Hodgkin
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