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NCT00546377 · ClinicalTrials.gov registry record · Phase 1
Pentostatin, Cyclophosphamide, Rituximab, and Mitoxantrone in Treating Patients With Chronic Lymphocytic Leukemia or Other Low-Grade B-Cell Cancer
A Phase 1 study of Lymphoma and Leukemia, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT00546377: Completed Phase 1 study of Lymphoma and Leukemia, sponsored by Memorial Sloan Kettering Cancer Center.
NCT00546377 is a Phase 1 study of Lymphoma and Leukemia that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 50 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00546377, a Phase 1 study of Lymphoma and Leukemia, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Pentostatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and mitoxantrone, 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, 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. Giving pentostatin together with combination chemotherapy and rituximab may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of mitoxantrone when given together with pentostatin, cyclophosphamide, and rituximab and to see how well it works in treating patients with chronic lymphocytic leukemia or other low-grade B-cell cancer.
Primary Outcome
Complete response (CR): Absence of lymphadenopathy, hepatomegaly or splenomegaly by physical examination and appropriate radiographic techniques (if abnormal pre-treatment): it is recognized that some patients with lymphoid malignancies who achieve a CR may have mild persistent abnormalities on CT Scan. Such abnormalities if stable on subsequent scanning will not be viewed as persistent disease in patients who otherwise meet the criteria for CR. Response will be assessed on an ongoing basis, but
Interventions
- DRUG cyclophosphamide
- BIOLOGICAL rituximab
- BIOLOGICAL filgrastim
- BIOLOGICAL pegfilgrastim
- BIOLOGICAL sargramostim
Study Locations (1)
New York
- Memorial Sloan-Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2005-07 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
What the finished NCT00546377 record still lists
NCT00546377 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (90% 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.
NCT00546377 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00546377 about?
NCT00546377 is a clinical study titled "Pentostatin, Cyclophosphamide, Rituximab, and Mitoxantrone in Treating Patients With Chronic Lymphocytic Leukemia or Other Low-Grade B-Cell Cancer". RATIONALE: Pentostatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from di...
What is the current status of trial NCT00546377?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2005-07. Estimated completion is 2014-05.
What conditions does trial NCT00546377 study?
This clinical trial studies the following conditions: Lymphoma, Leukemia.
What interventions are being tested in trial NCT00546377?
The interventions under investigation include: cyclophosphamide (DRUG), rituximab (BIOLOGICAL), filgrastim (BIOLOGICAL), pegfilgrastim (BIOLOGICAL), sargramostim (BIOLOGICAL).
Who is sponsoring clinical trial NCT00546377?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00546377 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00546377's enrollment target sits among peer trials
50 148th of 299 higher than 145 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.
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