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NCT01397591 · ClinicalTrials.gov registry record · Phase 2
Ofatumumab and Bortezomib in Subjects With Relapsed CD20+Diffuse Large B Cell, Follicular, or Mantle Cell Lymphoma
A Phase 2 study, sponsored by OHSU Knight Cancer Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT01397591: Clinical Trial Phase 2 study, sponsored by OHSU Knight Cancer Institute.
NCT01397591 is a Phase 2 study that was terminated before completion, run by OHSU Knight Cancer Institute. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01397591, a Phase 2 study, was terminated before completion, sponsored by OHSU Knight Cancer Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
This phase II trial studies how well giving ofatumumab together with bortezomib works in treating patients with relapsed diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL), or mantle cell lymphoma (MCL). Monoclonal antibodies, such as ofatumumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving ofatumumab together with bortezomib may help kill more cancer cells
Primary Outcome
Based on International Working Group (IWG) criteria, recorded in four categories: Complete Response (CR), disappearance of all evidence of disease; Partial Response (PR), regression of measurable disease and no new sites of disease; Progressive Disease (PD), Any new lesion or increase by \>= 50% of previously involved sites from nadir. Stable Disease (SD), failure to attain CR/PR or PD. A response is defined to be either CR/PR. A failure in response includes SD/PD.
Interventions
- DRUG Bortezomib
- BIOLOGICAL Ofatumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2011-10 |
| Est. Completion | 2013-07 |
| Phase | Phase 2 |
Why NCT01397591 stopped before completion
NCT01397591 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Bortezomib is the first listed.
NCT01397591 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01397591 about?
NCT01397591 is a clinical study titled "Ofatumumab and Bortezomib in Subjects With Relapsed CD20+Diffuse Large B Cell, Follicular, or Mantle Cell Lymphoma". This phase II trial studies how well giving ofatumumab together with bortezomib works in treating patients with relapsed diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL), or mantle cell lymphoma (MCL). Monoclonal antibodies, such as ofatumumab, can block cancer growth in different way...
What is the current status of trial NCT01397591?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2011-10. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01397591?
The interventions under investigation include: Bortezomib (DRUG), Ofatumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01397591?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01397591's enrollment target sits among peer trials
3 2001st of 2000 the lowest 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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