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NCT00005803 · ClinicalTrials.gov registry record · Phase 1
Autologous Stem Cell Transplant Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoma
A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 76
- Enrollment target
NCT00005803: Completed Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
NCT00005803 is a Phase 1 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 76 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00005803, a Phase 1 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 76 participants
- Enrollment target
Study Summary
This phase I/II trial studies how well autologous stem cell transplant followed by donor stem cell transplant works in treating patients with lymphoma that has returned or does not respond to treatment. Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect).
Primary Outcome
Number of patients who engrafted by Day 56 post allogeneic transplant. Failure to engraft is defined as the absence of detectable donor cells in the marrow. The rates and accompanying confidence intervals associated with failure of engraftment at day +56 will be calculated after every 5th patient is enrolled on the study. If the lower limit to the appropriate one-sided 80% confidence interval exceeds 25%, this will be considered sufficient evidence of an excess "failure" rate and the study will
Interventions
- DRUG Cyclophosphamide
- DRUG Carmustine
- DRUG Cyclosporine
- PROCEDURE Autologous Hematopoietic Stem Cell Transplantation
- PROCEDURE Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 1999-09 |
| Est. Completion | 2018-10 |
| Phase | Phase 1 |
What the finished NCT00005803 record still lists
NCT00005803 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00005803 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00005803 about?
NCT00005803 is a clinical study titled "Autologous Stem Cell Transplant Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoma". This phase I/II trial studies how well autologous stem cell transplant followed by donor stem cell transplant works in treating patients with lymphoma that has returned or does not respond to treatment. Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to...
What is the current status of trial NCT00005803?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 1999-09. Estimated completion is 2018-10.
What interventions are being tested in trial NCT00005803?
The interventions under investigation include: Cyclophosphamide (DRUG), Carmustine (DRUG), Cyclosporine (DRUG), Autologous Hematopoietic Stem Cell Transplantation (PROCEDURE), Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT00005803?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00005803's enrollment target sits among peer trials
76 705th of 2000 higher than 1,290 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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