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NCT00869999 · ClinicalTrials.gov registry record · Phase 2
Everolimus Plus Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT00869999: Completed Phase 2 study, sponsored by Massachusetts General Hospital.
NCT00869999 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00869999, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
Everolimus is an oral mTOR inhibitor with demonstrated preliminary efficacy and safety in diffuse large B-cell lymphoma (DLBCL) in both preclinical and clinical studies. The purpose of this research study is to determine whether Everolimus plus rituximab is safe and effective in participants with relapsed or refractory DLBCL. Everolimus is an investigational drug that works by blocking a special protein that helps cancer cells grow. The safety and effectiveness of Everolimus in the treatment of DLBCL has not yet been fully determined and is still investigational. The other drug in this study, rituximab, is approved by the US Food and Drug Administration (FDA) for use in patients who have diffuse large B-cell lymphoma and certain other types of non-Hodgkin lymphoma. Rituximab is a drug that destroys both normal and cancerous B-cells.
Primary Outcome
Complete response plus partial response after 6 cycles. Response rate will be evaluated by using the modified Cheson criteria for lymphoma response. Complete response requires all of the following: 1) PET positive prior to therapy: mass of any size permitted if PET negative. Variable FDG-avid or PET negative prior to therapy: regression to normal size on CT (\</= 1.5cm in their greatest transverse diameter for nodes \>/= 1.5 cm before therapy) 2) Spleen (if enlarged before therapy) must have reg
Interventions
- DRUG Everolimus
- DRUG rituximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2009-05 |
| Est. Completion | 2011-11 |
| Phase | Phase 2 |
What the finished NCT00869999 record still lists
NCT00869999 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Everolimus is the first listed.
NCT00869999 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00869999 about?
NCT00869999 is a clinical study titled "Everolimus Plus Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma". Everolimus is an oral mTOR inhibitor with demonstrated preliminary efficacy and safety in diffuse large B-cell lymphoma (DLBCL) in both preclinical and clinical studies. The purpose of this research study is to determine whether Everolimus plus rituximab is safe and effective in participants with re...
What is the current status of trial NCT00869999?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2009-05. Estimated completion is 2011-11.
What interventions are being tested in trial NCT00869999?
The interventions under investigation include: Everolimus (DRUG), rituximab (DRUG).
Who is sponsoring clinical trial NCT00869999?
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 NCT00869999's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 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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