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NCT00562328 · ClinicalTrials.gov registry record · Phase 2
Rituximab, Alemtuzumab, and GM-CSF As First-Line Therapy in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia
A Phase 2 study of Leukemia, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
- 2
- Study locations
NCT00562328: Completed Phase 2 study of Leukemia, sponsored by Mayo Clinic.
NCT00562328 is a Phase 2 study of Leukemia that has completed, run by Mayo Clinic. The registered enrollment target is 33 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (93% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00562328, a Phase 2 study of Leukemia, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
- 2
- Study locations
Study Summary
RATIONALE: Monoclonal antibodies, such as rituximab and alemtuzumab, 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. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving monoclonal antibody therapy together with GM-CSF may be an effective treatment for early-stage chronic lymphocytic leukemia. PURPOSE: This phase II trial is studying the side effects of giving rituximab and alemtuzumab together with GM-CSF and to see how well it works in treating patients with early-stage chronic lymphocytic leukemia.
Primary Outcome
Response, as defined by the National Cancer Institute Working Group (NCIWG), requires the following for a period of at least 2 months: * CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate \& biopsy * PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, \>100,0
Conditions Studied
Interventions
- BIOLOGICAL Rituximab
- BIOLOGICAL Sargramostim
- BIOLOGICAL Alemtuzumab
Study Locations (2)
Arizona
- Mayo Clinic Scottsdale - Scottsdale
Minnesota
- Mayo Clinic Cancer Center - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2008-01 |
| Est. Completion | 2014-12-18 |
| Phase | Phase 2 |
What the finished NCT00562328 record still lists
NCT00562328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Rituximab is the first listed.
NCT00562328 reports a single indexed study location in Arizona, Minnesota.
Frequently Asked Questions
What is clinical trial NCT00562328 about?
NCT00562328 is a clinical study titled "Rituximab, Alemtuzumab, and GM-CSF As First-Line Therapy in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia". RATIONALE: Monoclonal antibodies, such as rituximab and alemtuzumab, 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. Colony-stimulating factors, such as GM-CS...
What is the current status of trial NCT00562328?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2008-01. Estimated completion is 2014-12-18.
What conditions does trial NCT00562328 study?
This clinical trial studies the following conditions: Leukemia.
What interventions are being tested in trial NCT00562328?
The interventions under investigation include: Rituximab (BIOLOGICAL), Sargramostim (BIOLOGICAL), Alemtuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00562328?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00562328 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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Where NCT00562328's enrollment target sits among peer trials
33 155th of 233 higher than 78 of 233 other Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leukemia 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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