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NCT00477412 · ClinicalTrials.gov registry record · Phase 1
Bortezomib, Rituximab and Combination Chemotherapy in Treating Participants With Mantle Cell Lymphoma
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 107
- Enrollment target
NCT00477412: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00477412 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 107 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00477412, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 107 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and best dose of bortezomib when given with rituximab and chemotherapy drugs and to see how well they work in treating participants with mantle cell lymphoma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, dexamethasone, methotrexate, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving bortezomib, rituximab and combination chemotherapy may work better at treating mantle cell lymphoma.
Primary Outcome
Determine the safety and the maximum tolerated dose (MTD) of bortezomib when added to the combination of rituximab, methotrexate, and cytarabine alternating with bortezomib, rituximab-hyperCVAD in patients with untreated aggressive mantle cell lymphoma.
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Dexamethasone
- DRUG Cytarabine
- DRUG Bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2007-04-03 |
| Est. Completion | 2020-10-28 |
| Phase | Phase 1 |
What the finished NCT00477412 record still lists
NCT00477412 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% higher).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00477412 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00477412 about?
NCT00477412 is a clinical study titled "Bortezomib, Rituximab and Combination Chemotherapy in Treating Participants With Mantle Cell Lymphoma". This phase I/II trial studies the side effects and best dose of bortezomib when given with rituximab and chemotherapy drugs and to see how well they work in treating participants with mantle cell lymphoma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell...
What is the current status of trial NCT00477412?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 107 participants. The study started on 2007-04-03. Estimated completion is 2020-10-28.
What interventions are being tested in trial NCT00477412?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Dexamethasone (DRUG), Cytarabine (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT00477412?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00477412's enrollment target sits among peer trials
107 531st of 2000 higher than 1,470 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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