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NCT00589563 · ClinicalTrials.gov registry record · Phase 2
Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant For Hematological Cancer
A Phase 2 study of Lymphoma and Leukemia, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 2
- Study locations
NCT00589563: Completed Phase 2 study of Lymphoma and Leukemia, sponsored by City of Hope Medical Center.
NCT00589563 is a Phase 2 study of Lymphoma and Leukemia that has completed, run by City of Hope Medical Center. The registered enrollment target is 32 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (93% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00589563, a Phase 2 study of Lymphoma and Leukemia, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 2
- Study locations
Study Summary
RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus, sirolimus, antithymocyte globulin, and methotrexate before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well sirolimus, tacrolimus, and antithymocyte globulin work in preventing graft-versus-host disease in patients undergoing a donor stem cell transplant for hematological cancer .
Primary Outcome
Patients were evaluated for the development of acute GVHD within the first 100 days post HSCT. The cumulative incidence of grade II-IV acute GVHD was determined using competing risk analysis. Competing risks for acute GVHD were death and nonengraftment.
Conditions Studied
Interventions
- DRUG cyclophosphamide
- DRUG fludarabine phosphate
- DRUG etoposide
- DRUG melphalan
- BIOLOGICAL anti-thymocyte globulin
Study Locations (2)
Arizona
- Banner Good Samaritan Medical Center - Phoenix
California
- City of Hope Comprehensive Cancer Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2007-05 |
| Est. Completion | 2012-02 |
| Phase | Phase 2 |
What the finished NCT00589563 record still lists
NCT00589563 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (93% lower).
The record links to 10 conditions, with Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00589563 reports a single indexed study location in Arizona, California.
Frequently Asked Questions
What is clinical trial NCT00589563 about?
NCT00589563 is a clinical study titled "Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant For Hematological Cancer". RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and hel...
What is the current status of trial NCT00589563?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2007-05. Estimated completion is 2012-02.
What conditions does trial NCT00589563 study?
This clinical trial studies the following conditions: Lymphoma, Leukemia, Myelodysplastic Syndromes, Multiple Myeloma and Plasma Cell Neoplasm, Infection.
What interventions are being tested in trial NCT00589563?
The interventions under investigation include: cyclophosphamide (DRUG), fludarabine phosphate (DRUG), etoposide (DRUG), melphalan (DRUG), anti-thymocyte globulin (BIOLOGICAL).
Who is sponsoring clinical trial NCT00589563?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00589563 being conducted?
This trial has 2 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lymphoma
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 NCT00589563's enrollment target sits among peer trials
32 209th of 299 higher than 88 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma 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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