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NCT00027820 · ClinicalTrials.gov registry record · Phase 1
Total-Body Irradiation and Fludarabine Phosphate Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies or Kidney Cancer
A Phase 1 study of Chronic Myelomonocytic Leukemia and Clear Cell Renal Cell Carcinoma, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 106
- Enrollment target
- 10
- Study locations
NCT00027820: Completed Phase 1 study of Chronic Myelomonocytic Leukemia and Clear Cell Renal Cell Carcinoma, sponsored by Fred Hutchinson Cancer Center.
NCT00027820 is a Phase 1 study of Chronic Myelomonocytic Leukemia and Clear Cell Renal Cell Carcinoma that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 106 participants, above the 87-participant average among 73 other Chronic Myelomonocytic Leukemia trials with a reported enrollment target (22% higher). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00027820, a Phase 1 study of Chronic Myelomonocytic Leukemia and Clear Cell Renal Cell Carcinoma, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 106 participants
- Enrollment target
- 10
- Study locations
Study Summary
This phase I/II trial studies whether a new kind of blood stem cell (bone marrow) transplant, that may be less toxic, is able to treat underlying blood cancer. Stem cells are "seed cells" necessary to make blood cells. Researchers want to see if using less radiation and less chemotherapy with new immune suppressing drugs will enable a stem cell transplant to work. Researchers are hoping to see a mixture of recipient and donor stem cells after transplant. This mixture of donor and recipient stem cells is called "mixed-chimerism". Researchers hope to see these donor cells eliminate tumor cells. This is called a "graft-versus-leukemia" response.
Primary Outcome
The goal is to reduce the risk in patients without preceding chemotherapy to \< 20% and with preceding chemotherapy to \< 10%.
Conditions Studied
Interventions
- RADIATION Total-Body Irradiation
- DRUG Fludarabine Phosphate
- PROCEDURE Peripheral Blood Stem Cell Transplantation
- DRUG Cyclosporine
- PROCEDURE Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Study Locations (10)
Other
- Universitaet Leipzig - Leipzig
- University of Torino - Torino
Arizona
- University of Arizona Health Sciences Center - Tucson
California
- Stanford University Hospitals and Clinics - Stanford
Georgia
- Emory University/Winship Cancer Institute - Atlanta
Oregon
- OHSU Knight Cancer Institute - Portland
Texas
- Baylor Medical Center at Garland - Garland
Utah
- Huntsman Cancer Institute/University of Utah - Salt Lake City
Washington
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2001-08 |
| Est. Completion | 2004-09-05 |
| Phase | Phase 1 |
What the finished NCT00027820 record still lists
NCT00027820 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, above the 87-participant average among 73 other Chronic Myelomonocytic Leukemia trials with a reported enrollment target (22% higher).
The record links to 10 conditions, with Chronic Myelomonocytic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Total-Body Irradiation is the first listed.
NCT00027820 lists 10 locations in 9 states (Other, Arizona, California).
Frequently Asked Questions
What is clinical trial NCT00027820 about?
NCT00027820 is a clinical study titled "Total-Body Irradiation and Fludarabine Phosphate Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies or Kidney Cancer". This phase I/II trial studies whether a new kind of blood stem cell (bone marrow) transplant, that may be less toxic, is able to treat underlying blood cancer. Stem cells are "seed cells" necessary to make blood cells. Researchers want to see if using less radiation and less chemotherapy with new im...
What is the current status of trial NCT00027820?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 106 participants. The study started on 2001-08. Estimated completion is 2004-09-05.
What conditions does trial NCT00027820 study?
This clinical trial studies the following conditions: Chronic Myelomonocytic Leukemia, Clear Cell Renal Cell Carcinoma, Adult Acute Myeloid Leukemia in Remission, Previously Treated Myelodysplastic Syndrome, Childhood Acute Lymphoblastic Leukemia in Remission.
What interventions are being tested in trial NCT00027820?
The interventions under investigation include: Total-Body Irradiation (RADIATION), Fludarabine Phosphate (DRUG), Peripheral Blood Stem Cell Transplantation (PROCEDURE), Cyclosporine (DRUG), Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT00027820?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00027820 being conducted?
This trial has 10 study locations across Arizona, California, Georgia, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Myelomonocytic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00027820's enrollment target sits among peer trials
106 15th of 73 higher than 59 of 73 other Chronic Myelomonocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Myelomonocytic Leukemia 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.
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