Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Jacksonville, Florida: 18-003965
- Rochester, Minnesota: 18-003965
NCT ID: NCT01722305, NCT03798314
Sponsor Protocol Number: MC178A
About this study
The purpose of this study is to evaluate the side effects and best dose of pomalidomide when given together with dexamethasone in treating patients with primary central nervous system lymphoma that has come back (relapsed) or does not respond to treatment (refractory) or intraocular lymphoma that is newly diagnosed, relapsed or refractory. Pomalidomide may stimulate the immune system to kill cancer cells. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, stopping them from dividing, or by stopping them from spreading. Giving pomalidomide together with dexamethasone may kill more cancer cells.