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NCT01688466 · ClinicalTrials.gov registry record · Phase 2
Pomalidomide for Chronic Graft-versus-Host Disease
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT01688466: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01688466 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 34 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01688466, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
Background: \- Pomalidomide is a drug that alters the body's immune response. It may help people who have chronic graft-versus-host disease (GvHD). GvHD may appear after a stem cell transplant, when immune cells in the transplant try to attack tissues in the person who received the transplant. GvHD is not easy to treat, and often does not respond to standard treatments. Researchers want to see if pomalidomide is a safe and effective treatment for GvHD. Objectives: \- To test the safety and effectiveness of pomalidomide for GvHD that has not responded to standard treatments. Eligibility: \- Individuals at least 18 years of age who have GvHD that has not responded to standard treatments. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will also be collected. A lung function test and imaging studies will also be given. * Participants will take pomalidomide capsules once a day for 4-week periods called cycles. * Treatment will be monitored with frequent blood tests and imaging studies. Saliva samples and skin and mouth tissue biopsies will also be collected during treatment. * Treatment will continue for six cycles (6 months), unless the GvHD gets worse or side effects are too severe. If the GvHD has improved at the end of the six cycles, participants may be able to continue to take pomalidomide for up to six more cycles.
Interventions
- DRUG Pomalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2012-08-30 |
| Est. Completion | 2019-05-20 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01688466
The ClinicalTrials.gov registry entry for NCT01688466 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 34 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 Pomalidomide is the first listed.
NCT01688466 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01688466 about?
NCT01688466 is a clinical study titled "Pomalidomide for Chronic Graft-versus-Host Disease". Background: \- Pomalidomide is a drug that alters the body's immune response. It may help people who have chronic graft-versus-host disease (GvHD). GvHD may appear after a stem cell transplant, when immune cells in the transplant try to attack tissues in the person who received the transplant. GvHD...
What is the current status of trial NCT01688466?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2012-08-30. Estimated completion is 2019-05-20.
What interventions are being tested in trial NCT01688466?
The interventions under investigation include: Pomalidomide (DRUG).
Who is sponsoring clinical trial NCT01688466?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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