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NCT01058239 · ClinicalTrials.gov registry record · Phase 2
Bortezomib Plus Rituximab for EBV+ PTLD
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT01058239: Completed Phase 2 study, sponsored by Massachusetts General Hospital.
NCT01058239 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01058239, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
Post transplant lymphoproliferative disease (PTLD) is a type of B-cell non-Hodgkin lymphoma that occurs in patients with weakened immune systems due to immunosuppressive medications taken after organ or stem cell transplantation. This is usually related to a virus called Epstein-Barr (EPV). Rituximab is a type of drug called an "antibody" that specifically destroys both normal and cancerous B-cells, and is commonly used for PTLD. Bortezomib is a drug that has been approved by the Food and Drug Administration (FDA) to treat multiple myeloma and a B-cell non-Hodgkin lymphoma called Mantle Cell Lymphoma, and shows significant activity in lymphoma cells caused by EBV. In this research study, we hope to learn if the addition of bortezomib to rituximab treatment can increase the rate of complete remissions and cures of PTLD after organ or stem cell transplant.
Primary Outcome
Overall response rate includes both complete and partial responses assessed by PET/CT following completion of therapy. Response was evaluated using the International Working Group criteria for lymphoma response. The complete list of criteria used to evaluate response is too long to be detailed in the allotted space here, but response is defined more generally as: * Complete Response (CR): Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if prese
Interventions
- DRUG rituximab
- DRUG bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2011-11 |
| Est. Completion | 2017-11 |
| Phase | Phase 2 |
What the finished NCT01058239 record still lists
NCT01058239 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which rituximab is the first listed.
NCT01058239 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01058239 about?
NCT01058239 is a clinical study titled "Bortezomib Plus Rituximab for EBV+ PTLD". Post transplant lymphoproliferative disease (PTLD) is a type of B-cell non-Hodgkin lymphoma that occurs in patients with weakened immune systems due to immunosuppressive medications taken after organ or stem cell transplantation. This is usually related to a virus called Epstein-Barr (EPV). Rituxima...
What is the current status of trial NCT01058239?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2011-11. Estimated completion is 2017-11.
What interventions are being tested in trial NCT01058239?
The interventions under investigation include: rituximab (DRUG), bortezomib (DRUG).
Who is sponsoring clinical trial NCT01058239?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01058239's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 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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