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A Phase I Study to Investigate the Safety and Clinical Activity of Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 mAb in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia

This study will evaluate the safety and clinical activity of idelalisib in combination with an anti-CD20 monoclonal antibody (mAb), a chemotherapeutic agent, an 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).

Stanford is now accepting new patients for this trial. Please contact Nini Estevez at 650725-4041 for more information.

Investigator(s):

Intervention(s):

  • drug : Fludarabine
  • drug : Everolimus
  • drug : Bortezomib
  • drug : Rituximab
  • drug : Lenalidomide
  • drug : Ofatumumab
  • drug : Chlorambucil
  • drug : Idelalisib
  • drug : Bendamustine

Phase: Phase 1

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Age ? 18 - Previously treated with relapsed or refractory disease (refractory defined as not responding to a standard regimen or progressing within 6 months of the last course of a standard regimen) - Disease status requirement: - For CLL patients, symptomatic disease that mandates treatment as defined by the International Workshop on Chronic Lymphocytic Lymphoma (IWCLL) 2008 criteria - For indolent NHL and MCL patients, measurable disease by CT scan defined as at least 1 lesion that measures > 2 cm in a single dimension - WHO performance status of ? 2 - For men and women of child-bearing potential, willing to use adequate contraception (ie, latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study. - For Cohort 7 only: Women of child bearing potential must have 2 negative pregnancy tests prior to starting Lenalidomide. - Able to provide written informed consent

External Links

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Contact information

Primary Contact:

Nini Estevez 650725-4041

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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