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NCT00633594 · ClinicalTrials.gov registry record · Phase 1
Rituximab, Lenalidomide, and Bortezomib in Mantle Cell Lymphoma
A Phase 1 study, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT00633594: Completed Phase 1 study, sponsored by SCRI Development Innovations.
NCT00633594 is a Phase 1 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00633594, a Phase 1 study, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
This is a Phase I/II multicenter, open-label, dose-escalation study of rituximab, bortezomib, and lenalidomide in the first-line or second-line treatment of patients with Mantle Cell Lymphoma (MCL).
Primary Outcome
Determination of the maximum tolerated dose (MTD) of lenalidomide combined with bortezomib and rituximab, defined as the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity according to the NCI CTCAE v. 4.03. MTD of Lenalidomide was tested, included with 1.3 mg/m2 subcutaneous (D1, 4, 8, 11) bortezomib, 375 mg/m2 (D1, 8, 15 of Cycle 1, D1 on subsequent cycles) rituximab. Three dose limiting toxicities were reported in two patients (grade 4 neutropenia and grade 3 neurop
Interventions
- DRUG Rituximab
- DRUG Lenalidomide
- DRUG Bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2008-06 |
| Est. Completion | 2016-11 |
| Phase | Phase 1 |
What the finished NCT00633594 record still lists
NCT00633594 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 3 interventions - of which Rituximab is the first listed.
NCT00633594 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00633594 about?
NCT00633594 is a clinical study titled "Rituximab, Lenalidomide, and Bortezomib in Mantle Cell Lymphoma". This is a Phase I/II multicenter, open-label, dose-escalation study of rituximab, bortezomib, and lenalidomide in the first-line or second-line treatment of patients with Mantle Cell Lymphoma (MCL).
What is the current status of trial NCT00633594?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2008-06. Estimated completion is 2016-11.
What interventions are being tested in trial NCT00633594?
The interventions under investigation include: Rituximab (DRUG), Lenalidomide (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT00633594?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00633594's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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