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NCT00383994 · ClinicalTrials.gov registry record · Phase 1
Immunotherapy With NK Cell, Rituximab and Rhu-GMCSF in Non-Myeloablative Allogeneic Stem Cell Transplantation
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT00383994: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00383994 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00383994, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find out if giving a boost of natural killer (NK) cells from a donor combined with Rituxan (rituximab), can help to control disease in patients who have already received an allogeneic stem cell transplant. The safety of this treatment will also be studied. Participants have recurrent chronic lymphocytic leukemia (CLL) or lymphoma after non-myeloablative stem cell transplantation. Primary Objectives: 1.0 To determine the safety of Natural Killer (NK) cells and Rituximab + rhu-Granulocyte-macrophage colony-stimulating factor (GMCSF) in patients with persistent or recurrent B-cell lymphoid malignancies after non-myeloablative stem cell transplantation. 2.0 To determine factors associated with response.
Primary Outcome
Maximum tolerated dose (MTD) is the highest dose with 10 patients treated and 5 or fewer patients with DLT.
Interventions
- DRUG Rituximab
- DRUG GM-CSF
- BIOLOGICAL NK Cell Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2006-09 |
| Est. Completion | 2019-07-22 |
| Phase | Phase 1 |
What the finished NCT00383994 record still lists
NCT00383994 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which Rituximab is the first listed.
NCT00383994 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00383994 about?
NCT00383994 is a clinical study titled "Immunotherapy With NK Cell, Rituximab and Rhu-GMCSF in Non-Myeloablative Allogeneic Stem Cell Transplantation". The goal of this clinical research study is to find out if giving a boost of natural killer (NK) cells from a donor combined with Rituxan (rituximab), can help to control disease in patients who have already received an allogeneic stem cell transplant. The safety of this treatment will also be studi...
What is the current status of trial NCT00383994?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2006-09. Estimated completion is 2019-07-22.
What interventions are being tested in trial NCT00383994?
The interventions under investigation include: Rituximab (DRUG), GM-CSF (DRUG), NK Cell Infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT00383994?
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 NCT00383994's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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