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NCT00078858 · ClinicalTrials.gov registry record · Phase 1
Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant
A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT00078858: Completed Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
NCT00078858 is a Phase 1 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 37 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00078858, a Phase 1 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study Summary
This phase I/II trial studies whether stopping cyclosporine before mycophenolate mofetil is better at reducing the risk of life-threatening graft-versus-host disease (GVHD) than the previous approach where mycophenolate mofetil was stopped before cyclosporine. The other reason this study is being done because at the present time there are no curative therapies known outside of stem cell transplantation for these types of cancer. Because of age or underlying health status, patients may have a higher likelihood of experiencing harm from a conventional blood stem cell transplant. This study tests whether this new blood stem cell transplant method can be made safer by changing the order and length of time that immune suppressing drugs are given after transplant.
Primary Outcome
Life-threatening GVHD defined as (1) death related to GVHD or its treatment, (2) disability caused by GVHD or its treatment (3) 3 or more major infections in a calendar year or (4) suicidal ideation because of GVHD.
Interventions
- DRUG fludarabine phosphate
- PROCEDURE peripheral blood stem cell transplantation
- DRUG cyclosporine
- RADIATION total-body irradiation
- PROCEDURE nonmyeloablative allogeneic hematopoietic stem cell transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2003-09 |
| Phase | Phase 1 |
What the finished NCT00078858 record still lists
NCT00078858 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 5 interventions - of which fludarabine phosphate is the first listed.
NCT00078858 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00078858 about?
NCT00078858 is a clinical study titled "Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant". This phase I/II trial studies whether stopping cyclosporine before mycophenolate mofetil is better at reducing the risk of life-threatening graft-versus-host disease (GVHD) than the previous approach where mycophenolate mofetil was stopped before cyclosporine. The other reason this study is being do...
What is the current status of trial NCT00078858?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2003-09.
What interventions are being tested in trial NCT00078858?
The interventions under investigation include: fludarabine phosphate (DRUG), peripheral blood stem cell transplantation (PROCEDURE), cyclosporine (DRUG), total-body irradiation (RADIATION), nonmyeloablative allogeneic hematopoietic stem cell transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT00078858?
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 NCT00078858's enrollment target sits among peer trials
37 1204th of 2000 higher than 791 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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