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NCT00625729 · ClinicalTrials.gov registry record · Phase 1
Donor Natural Killer Cell Infusion, Rituximab, Aldesleukin, and Chemotherapy in Treating Patients With Relapsed Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia
A Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT00625729: Clinical Trial Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
NCT00625729 is a Phase 1 study that was terminated before completion, run by Masonic Cancer Center, University of Minnesota. 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
NCT00625729, a Phase 1 study, was terminated before completion, sponsored by Masonic Cancer Center, University of Minnesota.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
RATIONALE: Aldesleukin may stimulate natural killer cells to kill cancer cells. Treating natural killer cells with aldesleukin in the laboratory may help the natural killer cells kill more cancer cells when they are put back in the body. Giving monoclonal antibodies, such as rituximab, and chemotherapy drugs, such as fludarabine and cyclophosphamide, before a donor natural killer cell infusion helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. PURPOSE: This phase I/II trial is studying how well giving rituximab and chemotherapy followed by a donor natural killer cell infusion that has been treated in the laboratory with aldesleukin followed by aldesleukin works in treating patients with non-Hodgkin lymphoma or chronic lymphocytic leukemia.
Primary Outcome
Successful natural killer (NK) cell expansion will be defined as an absolute circulating donor-derived NK cell count of \>100 cells/μl 14 days after infusion with \<5% donor T and B cells in the mononuclear population.
Interventions
- DRUG cyclophosphamide
- BIOLOGICAL rituximab
- DRUG fludarabine phosphate
- BIOLOGICAL aldesleukin
- BIOLOGICAL allogeneic natural killer cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2008-01 |
| Est. Completion | 2010-04 |
| Phase | Phase 1 |
Why NCT00625729 stopped before completion
NCT00625729 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 5 interventions - of which cyclophosphamide is the first listed.
NCT00625729 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00625729 about?
NCT00625729 is a clinical study titled "Donor Natural Killer Cell Infusion, Rituximab, Aldesleukin, and Chemotherapy in Treating Patients With Relapsed Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia". RATIONALE: Aldesleukin may stimulate natural killer cells to kill cancer cells. Treating natural killer cells with aldesleukin in the laboratory may help the natural killer cells kill more cancer cells when they are put back in the body. Giving monoclonal antibodies, such as rituximab, and chemother...
What is the current status of trial NCT00625729?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2008-01. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00625729?
The interventions under investigation include: cyclophosphamide (DRUG), rituximab (BIOLOGICAL), fludarabine phosphate (DRUG), aldesleukin (BIOLOGICAL), allogeneic natural killer cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT00625729?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00625729'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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