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NCT00110058 · ClinicalTrials.gov registry record · Phase 2
Fludarabine and Radiation Therapy in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Chronic Phase or Accelerated Phase Chronic Myelogenous Leukemia
A Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT00110058 is a Phase 2 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 40 participants.
The verdict
NCT00110058, a Phase 2 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy 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 system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) or interferon alfa after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving fludarabine together with radiation therapy works in treating patients who are undergoing donor stem cell transplant for chronic phase or accelerated phase chronic myelogenous leukemia.
Interventions
- DRUG fludarabine phosphate
- DRUG imatinib mesylate
- DRUG cyclosporine
- BIOLOGICAL recombinant interferon alfa
- BIOLOGICAL therapeutic allogeneic lymphocytes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2005-02 |
| Est. Completion | 2006-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00110058
The ClinicalTrials.gov registry entry for NCT00110058 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which fludarabine phosphate is the first listed.
NCT00110058 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00110058 about?
NCT00110058 is a clinical study titled "Fludarabine and Radiation Therapy in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Chronic Phase or Accelerated Phase Chronic Myelogenous Leukemia". RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy 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 ...
What is the current status of trial NCT00110058?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2005-02. Estimated completion is 2006-07.
What interventions are being tested in trial NCT00110058?
The interventions under investigation include: fludarabine phosphate (DRUG), imatinib mesylate (DRUG), cyclosporine (DRUG), recombinant interferon alfa (BIOLOGICAL), therapeutic allogeneic lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT00110058?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
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