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NCT00433537 · ClinicalTrials.gov registry record · Phase 2
Combination Chemotherapy and Rituximab in Treating Patients With Untreated Mantle Cell Lymphoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 77
- Enrollment target
NCT00433537: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00433537 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 77 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00433537, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 77 participants
- Enrollment target
Study Summary
This phase II trial is studying how well giving rituximab together with combination chemotherapy and bortezomib works in treating patients with untreated mantle cell lymphoma. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving rituximab together with combination chemotherapy and bortezomib may kill more cancer cells. Treatment consists of six agents: bortezomib (Vc), rituximab (R), cyclophosphamide (C), vincristine (V), doxorubicin (A), and dexamethasone (D) (VcR-CVAD).
Primary Outcome
Number of eligible, treated participants who achieve complete response. Response criteria are based upon the criteria from the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Complete response is defined as complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy.
Interventions
- DRUG cyclophosphamide
- BIOLOGICAL rituximab
- DRUG vincristine
- DRUG doxorubicin hydrochloride
- DRUG bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2007-05 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
What the finished NCT00433537 record still lists
NCT00433537 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00433537 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00433537 about?
NCT00433537 is a clinical study titled "Combination Chemotherapy and Rituximab in Treating Patients With Untreated Mantle Cell Lymphoma". This phase II trial is studying how well giving rituximab together with combination chemotherapy and bortezomib works in treating patients with untreated mantle cell lymphoma. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells ...
What is the current status of trial NCT00433537?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2007-05. Estimated completion is 2013-06.
What interventions are being tested in trial NCT00433537?
The interventions under investigation include: cyclophosphamide (DRUG), rituximab (BIOLOGICAL), vincristine (DRUG), doxorubicin hydrochloride (DRUG), bortezomib (DRUG).
Who is sponsoring clinical trial NCT00433537?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00433537's enrollment target sits among peer trials
77 891st of 2000 higher than 1,108 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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