Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy (A+B)
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|ClinicalTrials.gov Identifier: NCT01077518|
Recruitment Status : Terminated (efficacy analysis for primary endpoint not statistically significant)
First Posted : March 1, 2010
Last Update Posted : October 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Follicular||Drug: Ofatumumab (Arm A) Drug: Bendamustine infusion (Arm B) Drug: Bendamustine infusion (Arm A)||Phase 3|
Ofatumumab is an anti-CD20 monoclonal antibody shown to have monotherapy activity in patients with follicular lymphoma that has relapsed following rituximab-containing therapy. Bendamustine was approved by FDA for the treatment of in patients with indolent B-cell Non-Hodgkin's Lymphoma (NHL) that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.
Biologics have demonstrated enhanced efficacy when added to chemotherapeutic combinations in the frontline treatment for indolent NHL. The combination of ofatumumab and bendamustine may provide additional clinical benefit and efficacy to those who no longer respond to rituximab or rituximab-containing regimens.
The objective of this study is to determine the effect of ofatumumab and bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||345 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||randomized open label bendamustine monotherapy vs. ofatumumab|
|Masking:||None (Open Label)|
|Official Title:||Randomized Open Label of Ofatumumab and Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin's Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment|
|Actual Study Start Date :||August 26, 2010|
|Actual Primary Completion Date :||January 3, 2018|
|Actual Study Completion Date :||December 26, 2018|
Experimental: Ofatumumab and Bendamustine (Arm A)
Up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and q28 days when given as monotherapy)
Drug: Ofatumumab (Arm A)
Ofatumumab will be given on day 1 of each cycle of bendamustine as long as patients in Arm A receive bendamustine. Once patients in Arm A complete bendamustine therapy, the remaining doses of ofatumumab will be given monthly until all 12 doses are completed.
Drug: Bendamustine infusion (Arm A)
Up to 8 cycles of Bendamustine (90 mg/m2 Days 1 and 2, every 21 days) given in combination with 12 doses of ofatumumab (1000 mg).
Active Comparator: Bendamustine (Arm B)
Up to 8 cycles of bendamustine (120 mg/m2) on Days 1,2 every 21 days
Drug: Bendamustine infusion (Arm B)
Bendamustine (120 mg/m2 Days 1 and 2, every 21 days, up to 8 cycles).
- Progression-free-survival following ofatumumab and bendamustine combination therapy [ Time Frame: 89 months ]
- Clinical benefit, changes in patient reported outcome measures, and pharmacokinetics following ofatumumab and bendamustine combination therapy [ Time Frame: 89 months ]
- Overall response rate, overall survival, time to and duration of response following ofatumumab and bendamustine combination therapy [ Time Frame: 89 months ]
- Safety and tolerability of ofatumumab and bendamustine combination therapy [ Time Frame: 157 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01077518
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|