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NCT00450801 · ClinicalTrials.gov registry record · Phase 2
R-MACLO-IVAM and Thalidomide in Untreated Mantle Cell Lymphoma
A Phase 2 study, sponsored by University of Miami.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT00450801: Completed Phase 2 study, sponsored by University of Miami.
NCT00450801 is a Phase 2 study that has completed, run by University of Miami. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00450801, a Phase 2 study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
RATIONALE: To evaluate the efficacy of a new high intensity chemotherapy regimen with thalidomide maintenance in patients with newly diagnosed mantle cell lymphoma PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy followed by thalidomide works in treating patients with previously untreated mantle cell lymphoma.
Primary Outcome
Percentage of participants achieving progression-free survival at 1, 3 and 5 years after the start of protocol therapy, based upon the International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL). Progression is defined as a ≥ 50% increase from nadir in the product of the two largest perpendicular diameters (PPD-size) of any previously identified abnormal node, or appearance of any new lesion.
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Rituximab
- DRUG Etoposide
- DRUG Cytarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2004-04 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
What the finished NCT00450801 record still lists
NCT00450801 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00450801 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00450801 about?
NCT00450801 is a clinical study titled "R-MACLO-IVAM and Thalidomide in Untreated Mantle Cell Lymphoma". RATIONALE: To evaluate the efficacy of a new high intensity chemotherapy regimen with thalidomide maintenance in patients with newly diagnosed mantle cell lymphoma PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy followed by thalidomide works...
What is the current status of trial NCT00450801?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2004-04. Estimated completion is 2015-07.
What interventions are being tested in trial NCT00450801?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Rituximab (DRUG), Etoposide (DRUG), Cytarabine (DRUG).
Who is sponsoring clinical trial NCT00450801?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00450801's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 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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