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NCT00066469 · ClinicalTrials.gov registry record · Phase 2
Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation
A Phase 2 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
NCT00066469: Completed Phase 2 study, sponsored by Children's Oncology Group.
NCT00066469 is a Phase 2 study that has completed, run by Children's Oncology Group. The registered enrollment target is 55 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00066469, a Phase 2 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy such as cyclophosphamide, prednisone, and methylprednisolone use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining cyclophosphamide and either prednisone or methylprednisolone with rituximab may be effective in treating lymphoproliferative disease following organ transplantation. PURPOSE: Phase II trial to study the effectiveness of combining cyclophosphamide and either prednisone or methylprednisolone with rituximab in treating patients who have Epstein-Barr virus-positive lymphoproliferative disease following organ transplantation.
Primary Outcome
Alive in continuous complete remission with functioning original allograft. The Event Free Survival (EFS) will be estimated by the Kaplan-Meier method.
Interventions
- DRUG prednisone
- DRUG cyclophosphamide
- BIOLOGICAL rituximab
- DRUG methylprednisolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2004-04 |
| Est. Completion | 2013-12-31 |
| Phase | Phase 2 |
What the finished NCT00066469 record still lists
NCT00066469 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 4 interventions - of which prednisone is the first listed.
NCT00066469 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00066469 about?
NCT00066469 is a clinical study titled "Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation". RATIONALE: Drugs used in chemotherapy such as cyclophosphamide, prednisone, and methylprednisolone use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substan...
What is the current status of trial NCT00066469?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2004-04. Estimated completion is 2013-12-31.
What interventions are being tested in trial NCT00066469?
The interventions under investigation include: prednisone (DRUG), cyclophosphamide (DRUG), rituximab (BIOLOGICAL), methylprednisolone (DRUG).
Who is sponsoring clinical trial NCT00066469?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00066469's enrollment target sits among peer trials
55 1153rd of 2000 higher than 841 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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