Bendamustine Hydrochloride in Combination With Rituximab in Patients With Relapsed Refractory Mantle Cell Lymphoma

Part of paid clinical trials in Fountain Valley, California.

Sponsor
Cephalon
Study ID
NCT00891839
Phase
PHASE2
Status
Completed

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bendamustine — DRUG
    Bendamustine at 90 mg/m\^2 intravenously (iv) on days 1 and 2 of each 28-day cycle. Dosage calculations for bendamustine are based on the patient's body surface area (BSA) at baseline, using actual weight for calculations. If there is a 10% change in a patient's weight during treatment, the most recent weight is used to recalculate the BSA. The new BSA is used in determining the doses to be administered in any subsequent cycles.
  • Rituximab — DRUG
    Patients receive 375 mg/m\^2 of rituximab, administered by iv infusion on day 1 of every 28-day cycle of treatment. Dosage calculations for rituximab are based on the patient's BSA at baseline, using actual weight for calculations. If there is a 10% change in a patient's weight during treatment, the most recent weight is used to recalculate the BSA. The new BSA is used in determining the doses to be administered in any subsequent cycles.

Study Details

The purpose of this study is to determine the efficacy and safety of the combination of bendamustine and rituximab in patients with relapsed/refractory mantle cell lymphoma.

Key Dates

Start date
Jun 30, 2009
Status verified
Oct 2014
Primary completion
Dec 31, 2011
Completion
May 31, 2014

Study Design

Enrollment
45 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bendamustine+Rituximab
    Patients receive bendamustine at 90 mg/m\^2 intravenously (iv) on days 1 and 2, and 375 mg/m\^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).

Primary Outcome Measure

Overall Response Rate (Complete Response + Partial Response) at the End of Cycles 3 and 6 Using the 2007 International Working Group Criteria [ Time Frame: Month 3 (end of cycle 3), Month 6 (end of cycle 6) ]

Locations (11)

FacilityCityStateZIPSite coordinators
Teva Investigational Site 11Fountain ValleyCalifornia--
Teva Investigational Site 2Los AngelesCalifornia--
Teva Investigational Site 35OrlandoFlorida--
Teva Investigational Site 30LafayetteIndiana--
Teva Investigational Site 20BethesdaMaryland--
Teva Investigational Site 4HackensackNew Jersey--
Teva Investigational Site 3BuffaloNew York--
Teva Investigational Site 43GettysburgPennsylvania--
Teva Investigational Site 33BryanTexas--
Teva Investigational Site 41GrapevineTexas--
Teva Investigational Site 23LynchburgVirginia--

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