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NCT00940342 · ClinicalTrials.gov registry record · Phase 2
Rituximab Plus Sargramostim (GM-CSF) In Patients With Chronic Lymphocytic Leukemia
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
NCT00940342: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00940342 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 130 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00940342, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if giving granulocyte-macrophage colony-stimulating factor (GM-CSF) together with rituximab can improve the ability of rituximab to shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL). The safety of this combination treatment will also be studied.
Primary Outcome
Overall Response Rate - Complete Response (CR) + Partial Response (PR). CR is the absence of Lymphocyte infiltrates on biopsy, \<30% Lymphocytes on Bone Marrow Aspirate, Lymphocytes \< 4,000ul , Hemoglobin \>11.0 g/dl , Platelets \>1000,000/ul, Polymorphonuclear neutrophils (PMN) \>1,500/ul, Liver/Spleen not palpable, Nodes none. PR is \<30% Lymphocytes with residual disease on biopsy for nodular PR, Lymphocytes \>50% decrease, Hemoglobin (un-transfused) \> 11.0 g/dl or \>50% improvement from ba
Interventions
- DRUG Rituximab
- DRUG GM-CSF (Sargramostim)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2004-10-12 |
| Est. Completion | 2017-01-05 |
| Phase | Phase 2 |
What the finished NCT00940342 record still lists
NCT00940342 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.
NCT00940342 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00940342 about?
NCT00940342 is a clinical study titled "Rituximab Plus Sargramostim (GM-CSF) In Patients With Chronic Lymphocytic Leukemia". The goal of this clinical research study is to learn if giving granulocyte-macrophage colony-stimulating factor (GM-CSF) together with rituximab can improve the ability of rituximab to shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL). The safety of this combination treatment will also...
What is the current status of trial NCT00940342?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2004-10-12. Estimated completion is 2017-01-05.
What interventions are being tested in trial NCT00940342?
The interventions under investigation include: Rituximab (DRUG), GM-CSF (Sargramostim) (DRUG).
Who is sponsoring clinical trial NCT00940342?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00940342's enrollment target sits among peer trials
130 543rd of 2000 higher than 1,448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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