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NCT00381004 · ClinicalTrials.gov registry record · Phase 2
FCR Plus Sargramostim (GM-CSF) as Frontline Therapy for Symptomatic Chronic Lymphocytic Leukemia
A Phase 2 study of Chronic Lymphocytic Leukemia, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT00381004 is a Phase 2 study of Chronic Lymphocytic Leukemia that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 60 participants, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00381004, a Phase 2 study of Chronic Lymphocytic Leukemia, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical research study is to learn if using a combination of fludarabine, cyclophosphamide, and rituximab, with sargramostim (GM-CSF) can help to control previously untreated chronic lymphocytic leukemia (CLL). The safety of this combination will also be studied. This study will evaluate antibody-dependent cellular cytotoxicity (ADCC) and its relationship to response.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Rituximab
- DRUG Sargramostim
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2006-09 |
| Est. Completion | 2014-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00381004
The ClinicalTrials.gov registry entry for NCT00381004 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (67% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT00381004 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00381004 about?
NCT00381004 is a clinical study titled "FCR Plus Sargramostim (GM-CSF) as Frontline Therapy for Symptomatic Chronic Lymphocytic Leukemia". The goal of this clinical research study is to learn if using a combination of fludarabine, cyclophosphamide, and rituximab, with sargramostim (GM-CSF) can help to control previously untreated chronic lymphocytic leukemia (CLL). The safety of this combination will also be studied. This study will ev...
What is the current status of trial NCT00381004?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2006-09. Estimated completion is 2014-12.
What conditions does trial NCT00381004 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia.
What interventions are being tested in trial NCT00381004?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Rituximab (DRUG), Sargramostim (DRUG).
Who is sponsoring clinical trial NCT00381004?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00381004 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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