Study to Investigate Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 Monoclonal Antibody (mAb) in Participants With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or
Completed
Gilead Sciences
Phase 1
2010-03-25
The primary objective of the study is to evaluate the safety of idelalisib in combination
with an anti-CD20 monoclonal antibody (mAb), a chemotherapeutic agent, a mammalian target of
rapamycin (mTOR) inhibitor, a protease inhibitor, an antiangiogenic agent, and/or an
immunomodulatory agent in participants with relapsed or refractory indolent B-cell
non-Hodgkin lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia
(CLL).
An Extension Study for Subjects Who Are Deriving Benefit With Idelalisib (GS-1101; CAL-101) Following Completion of a Prior Idelalisib Study
Terminated
Gilead Sciences
Phase 1/Phase 2
2010-03-22
This is a long-term safety extension study of idelalisib (GS-1101; CAL-101) in patients with
hematologic malignancies who complete other idelalisib studies. It provides the opportunity
for patients to continue treatment as long as the patient is deriving clinical benefit.
Patients will be followed according to the standard of care as appropriate for their type of
cancer. The dose of idelalisib will generally be the same as the dose that was administered
at the end of the prior study, but may be titrated up to improve clinical response or down
for toxicity. Patients will be withdrawn from the study if they develop progressive disease,
unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in
the opinion of the investigator.
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