Immunochemotherapy With Rituximab-Bendamustine-Cytarabine (R-BAC) for Patients With Mantle Cell Lymphoma
- Sponsor
- St. Bortolo Hospital
- Study ID
- NCT00992134
- Phase
- PHASE2
- Status
- Completed
Conditions
- Lymphoma, Mantle-Cell
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Rituximab, Bendamustine, Cytarabine — DRUGRituximab IV 375 mg/m2 on day 1. Bendamustine IV 70 mg/m2 over a 30-60 minute infusion on day 1 and 2. Cytarabine IV 800 mg/m2, over a 2-hour infusion, 2 hours after Bendamustine, on Day 1, 2, and 3. Four to six cycles. Recycle every 28 days.
Study Details
The objective of the study is to demonstrate the safety, tolerability, and activity of Rituximab-Bendamustine-Cytarabine(R-BAC) regimen in patients with mantle cell lymphoma (MCL) aged 65 years or more, as well as in younger patients who are not eligible for intensive regimens including/not including autologous transplantation.
Key Dates
- Start date
- Jun 30, 2009
- Status verified
- Sep 2010
- Primary completion
- Jun 30, 2011
- Completion
- Jun 30, 2012
Study Design
- Enrollment
- 41 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Primary Outcome Measure
The safety and tolerability of R-BAC treatment will be tested to determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of Ara-C when combined with Bendamustine and Rituximab. [ Time Frame: June 2011 ]