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NCT01286272 · ClinicalTrials.gov registry record · Phase 2
Ofatumumab and Bendamustine Hydrochloride With or Without Bortezomib in Treating Patients With Untreated Follicular Non-Hodgkin Lymphoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 135
- Enrollment target
NCT01286272: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01286272 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 135 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01286272, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 135 participants
- Enrollment target
Study Summary
This randomized phase II trial studies how well ofatumumab and bendamustine hydrochloride with or without bortezomib works in treating patients with untreated follicular non-Hodgkin lymphoma. Monoclonal antibodies, such as ofatumumab, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of cancer cells by blocking blood flow to the tumor. It is not yet known whether ofatumumab and bendamustine hydrochloride are more effective with bortezomib in treating patients with follicular non-Hodgkin lymphoma.
Primary Outcome
A complete response was defined using International Harmonization Project Response Criteria as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. If the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. The complete response (CR) rate was calculated in newly diagnosed untreated follicular lymphoma patients receiving 6 cycles of ofatumumab-bendamustin
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Bortezomib
- RADIATION Fludeoxyglucose F-18
- DRUG Bendamustine Hydrochloride
- BIOLOGICAL Ofatumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2011-04-28 |
| Est. Completion | 2025-09-02 |
| Phase | Phase 2 |
What the finished NCT01286272 record still lists
NCT01286272 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01286272 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01286272 about?
NCT01286272 is a clinical study titled "Ofatumumab and Bendamustine Hydrochloride With or Without Bortezomib in Treating Patients With Untreated Follicular Non-Hodgkin Lymphoma". This randomized phase II trial studies how well ofatumumab and bendamustine hydrochloride with or without bortezomib works in treating patients with untreated follicular non-Hodgkin lymphoma. Monoclonal antibodies, such as ofatumumab, may block cancer growth in different ways by targeting certain ce...
What is the current status of trial NCT01286272?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 135 participants. The study started on 2011-04-28. Estimated completion is 2025-09-02.
What interventions are being tested in trial NCT01286272?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Bortezomib (DRUG), Fludeoxyglucose F-18 (RADIATION), Bendamustine Hydrochloride (DRUG), Ofatumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01286272?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01286272's enrollment target sits among peer trials
135 532nd of 2000 higher than 1,464 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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