Trial of Rituximab, Bendamustine (RB) for Patients With Follicular Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line
- Sponsor
- Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas
- Study ID
- NCT01127841
- Phase
- PHASE2
- Status
- Unknown
Conditions
- Follicular Non-Hodgking´s Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line.
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Rituximab and Bendamustine — DRUGRituximab: 375 mg/m2/day, day 1 of each cycle, iv. Bendamustine: 90 mg/m2/day, days1 and 2 fo each cycle, iv.
Study Details
Evaluate the effectiveness of rituximab, bendamustine (r) in terms of complete response and response complete not confirmed.
Key Dates
- Start date
- Jul 31, 2009
- Status verified
- Aug 2013
- Primary completion
- Dec 31, 2013
- Completion
- Dec 31, 2015
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Rituximab and Bendamustine
Primary Outcome Measure
the primary endpoint is the complete response and unconfirmed complete response according to the criteria of the International Workshop to Standardize Response Criteria for NHL [ Time Frame: Four years ]