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NCT01497275 · ClinicalTrials.gov registry record · Phase 2
Zevalin and Velcade in Relapsed/Refractory Mantle Cell Lymphoma
A Phase 2 study, sponsored by Duke University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT01497275: Clinical Trial Phase 2 study, sponsored by Duke University.
NCT01497275 is a Phase 2 study that was terminated before completion, run by Duke University. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01497275, a Phase 2 study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effects (good and bad) of the combination of ibritumomab tiuxetan (Zevalin) and bortezomib (Velcade) in patients with relapsed/refractory mantle cell lymphoma. Zevalin is a monoclonal antibody that is combined with a radioactive substance and given with another monoclonal antibody called rituximab (Rituxan). It works by attaching to cancer cells and releasing radiation to damage those cells. Both Zevalin and Rituxan are given in this study, along with Velcade.
Primary Outcome
Disease will be assessed every 3 months. The Cheson criteria will be used to define response: Complete Response = Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present prior to therapy. Partial Response = A decrease of ≥ 50% in the sum of the products of their greatest transverse diameters (SPD) of up to six of the largest dominant nodes or nodal masses. These nodes or masses should be selected accor
Interventions
- DRUG Rituximab, Bortezomib,Y90 ibritumomab tiuxetan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2012-02 |
| Est. Completion | 2014-05 |
| Phase | Phase 2 |
Why NCT01497275 stopped before completion
NCT01497275 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Rituximab, Bortezomib,Y90 ibritumomab tiuxetan is the first listed.
NCT01497275 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01497275 about?
NCT01497275 is a clinical study titled "Zevalin and Velcade in Relapsed/Refractory Mantle Cell Lymphoma". The purpose of this study is to evaluate the effects (good and bad) of the combination of ibritumomab tiuxetan (Zevalin) and bortezomib (Velcade) in patients with relapsed/refractory mantle cell lymphoma. Zevalin is a monoclonal antibody that is combined with a radioactive substance and given with ...
What is the current status of trial NCT01497275?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2012-02. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01497275?
The interventions under investigation include: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan (DRUG).
Who is sponsoring clinical trial NCT01497275?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01497275's enrollment target sits among peer trials
5 2000th 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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