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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: Completed Phase 2 study of Chronic Lymphocytic Leukemia, sponsored by M.D. Anderson Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Complete Remission:Normal exam/No symptoms; Absolute lymphocyte count (ALC)\</=4x10\^9/L, Hb\>11 g/dL, absolute neutrophil count (ANC)\>/=1.5x109/L, \& platelet count\>100x109/L. Bone marrow:\<30% lymphocytes aspirate no biopsy evidence disease; Disappearance palpable lymph nodes/spleen/liver, no new lesions. Partial Remission:ALC reduced 50%,either Hb\>11 g/dL or 50% improvement (imp.) in deviation, or ANC\>/=1.5x109/L or 50% imp., or platelet\>100x109/L or 50% imp. in deviation from normal. Re
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 |
What the finished NCT00381004 record still lists
NCT00381004 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (67% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Chronic Lymphocytic Leukemia
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 NCT00381004's enrollment target sits among peer trials
60 88th of 187 higher than 95 of 187 other Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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