Waldenstrom's Macroglobulinemia Clinical Trial
Official title:
Phase II Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Idelalisib (GS-1101) in Waldenström Macroglobulinemia
This research study is evaluating a drug called idelalisib (formerly known as GS-1101 or CAL-101) as a possible treatment for Waldenstrom's Macroglobulinemia (WM).
This research study is a Phase II clinical trial. Phase II clinical trials test the
effectiveness of an investigational drug, idelalisib, to learn whether idelalisib works in
treating a specific cancer. "Investigational" means that idelalisib is still being studied
and that research doctors are trying to find out more about it-such as the safest dose to
use, the side effects it may cause, and if idelalisib is effective for treating different
types of cancer. Idelalisib has already been approved in the US by the FDA to treat patients
with relapsed chronic lymphocytic leukemia, follicular lymphoma and small lymphocytic
lymphoma.
Idelalisib is a newly discovered drug that is being developed as an anti-cancer agent. This
drug has been used in laboratory experiments and other research studies in B-cell
malignancies and information from those other research studies suggests that idelalisib may
help to target the tumor cells in B-cell malignancies, including WM. B cells are a type of
white blood cell responsible for making antibodies.
In this research study, the investigators are testing the safety and efficacy of idelalisib
as a treatment option for relapsed or refractory Waldenstrom's Macroglobulinemia.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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