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NCT00816595 · ClinicalTrials.gov registry record · Phase 2
Pentostatin, Cyclophosphamide, and Rituximab With or Without Bevacizumab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
A Phase 2 study of Lymphoma and Leukemia, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
- 2
- Study locations
NCT00816595: Completed Phase 2 study of Lymphoma and Leukemia, sponsored by Mayo Clinic.
NCT00816595 is a Phase 2 study of Lymphoma and Leukemia that has completed, run by Mayo Clinic. The registered enrollment target is 68 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (86% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00816595, a Phase 2 study of Lymphoma and Leukemia, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
- 2
- Study locations
Study Summary
RATIONALE: Drugs used in chemotherapy, such as pentostatin and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab and bevacizumab, 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. It is not yet known whether giving pentostatin and cyclophosphamide together with rituximab is more effective with or without bevacizumab in treating patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma. PURPOSE: This randomized phase II trial is studying the side effects of giving pentostatin and cyclophosphamide together with rituximab with or without bevacizumab and to see how well it works in treating patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma.
Primary Outcome
A Complete Response (CR) requires all of the following for 2 months: * Absence of lymphadenopathy by physical examination (PE) * No hepato- or splenomegaly by PE * Neutrophils \>1500/ul, Platelets \>100,000/ul. Hemoglobin \>11.0 gm/dl, Peripheral blood lymphocytes \<4000/uL Nodular Partial Response (nPR) is defined as a patient qualified for a CR, but regenerative nodules are histologically present on bone marrow samples. A Clinical Complete Response (CCR) is defined as a patient qualified fo
Interventions
- DRUG cyclophosphamide
- BIOLOGICAL rituximab
- BIOLOGICAL bevacizumab
- BIOLOGICAL pegfilgrastim
- DRUG pentostatin
Study Locations (2)
Arizona
- Mayo Clinic in Arizona - Scottsdale
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2009-02 |
| Est. Completion | 2016-11-29 |
| Phase | Phase 2 |
What the finished NCT00816595 record still lists
NCT00816595 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (86% lower).
The record links to 2 conditions, with Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00816595 reports a single indexed study location in Arizona, Minnesota.
Frequently Asked Questions
What is clinical trial NCT00816595 about?
NCT00816595 is a clinical study titled "Pentostatin, Cyclophosphamide, and Rituximab With or Without Bevacizumab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma". RATIONALE: Drugs used in chemotherapy, such as pentostatin and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab and bevacizumab, can block cancer growth in different wa...
What is the current status of trial NCT00816595?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2009-02. Estimated completion is 2016-11-29.
What conditions does trial NCT00816595 study?
This clinical trial studies the following conditions: Lymphoma, Leukemia.
What interventions are being tested in trial NCT00816595?
The interventions under investigation include: cyclophosphamide (DRUG), rituximab (BIOLOGICAL), bevacizumab (BIOLOGICAL), pegfilgrastim (BIOLOGICAL), pentostatin (DRUG).
Who is sponsoring clinical trial NCT00816595?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00816595 being conducted?
This trial has 2 study locations across Arizona, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00816595's enrollment target sits among peer trials
68 119th of 299 higher than 180 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma 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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