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NCT00702689 · ClinicalTrials.gov registry record · Phase 2
Imatinib Mesylate to Treat Skin Changes in Patients With Chronic Graft-Versus-Host Disease
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT00702689: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00702689 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00702689, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
Background: Chronic graft-versus-host disease (GVHD) is a common complication of stem cell transplant, resulting from the donor's immune cells attacking the cells of the body of the recipient. One effect of GVHD is fibrosis (scarring) of the skin that can lead to impaired function, decreased quality of life and increased risk of death. This is known as sclerotic skin changes of GVHD, or sclerodermatous graft versus host disease (ScGVHD). Imatinib mesylate (Gleevec) is a drug that has been approved by the Food and Drug Administration to treat cancer in humans and fibrosing conditions in animals. Objectives: To see if imatinib mesylate can improve ScGVHD and evaluate its effect on other GVHD symptoms To assess the side effects of imatinib mesylate in patients with GVHD To evaluate blood, body fluids and tissue samples in patients to try to better understand the biology of ScGVHD Eligibility: Patients 4 years of age and older with ScGVHD Design: Initial treatment: Participants take imatinib mesylate tablets once a day for up to 6 months, as long as their GVHD does not get worse and they do not develop unacceptable side effects of the drug. Evaluations: Participants are evaluated at 1, 3 and 6 months at the National Institutes of Health (NIH) Clinical Center with procedures that may include the following: Medical history and physical examination Blood and urine tests Lung function test Skin biopsy Magnetic resonance imaging (MRI) scan Specialty consultations (e.g., physical or rehabilitative therapy, dentist, eye doctor, dermatologist) Electrocardiogram (EKG) Echocardiogram (ultrasound test of the heart) Muga scan (nuclear medicine test of the heart) Quality-of-life questionnaires Apheresis (procedure for collecting quantities of white blood cells) Office visits with local physician once a week for 1 month, then once every 2 weeks for 5 months Followup visits at National Institutes of Health (NIH) every 6 months for 1 year Continuing treatment:
Interventions
- DRUG Gleevec, STI571(Imatinib Mesylate)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2008-12-15 |
| Est. Completion | 2020-02-26 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00702689
The ClinicalTrials.gov registry entry for NCT00702689 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Gleevec, STI571(Imatinib Mesylate) is the first listed.
NCT00702689 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00702689 about?
NCT00702689 is a clinical study titled "Imatinib Mesylate to Treat Skin Changes in Patients With Chronic Graft-Versus-Host Disease". Background: Chronic graft-versus-host disease (GVHD) is a common complication of stem cell transplant, resulting from the donor's immune cells attacking the cells of the body of the recipient. One effect of GVHD is fibrosis (scarring) of the skin that can lead to impaired function, decreased qualit...
What is the current status of trial NCT00702689?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2008-12-15. Estimated completion is 2020-02-26.
What interventions are being tested in trial NCT00702689?
The interventions under investigation include: Gleevec, STI571(Imatinib Mesylate) (DRUG).
Who is sponsoring clinical trial NCT00702689?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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