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Alkylating agents
Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy (A+B Trial)
Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up c1d1, c7d1, c12d1, c1d1, c12d1, 12m post-d252, withdrawal up to 12 months follow up
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Pivotal Trial
Summary
The purpose of this study was to evaluate the safety and efficacy 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.
Eligible Conditions
- Follicular Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ c1d1, c7d1, c12d1, c1d1, c12d1, 12m post-d252, withdrawal up to 12 months follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~c1d1, c7d1, c12d1, c1d1, c12d1, 12m post-d252, withdrawal up to 12 months follow up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)
Secondary study objectives
B-cell Monitoring (CD19+, CD20+)
Duration of Response in All Participants Per IRC
Duration of Response in Participants With FL Per IRC
+24 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Ofatumumab and Bendamustine (Arm A)Experimental Treatment2 Interventions
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)
Group II: Bendamustine (Arm B)Active Control3 Interventions
Up to 8 cycles of bendamustine (120 mg/m2) on Days 1,2 every 21 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ofatumumab
FDA approved
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,921 Previous Clinical Trials
4,253,966 Total Patients Enrolled