New Clinical Trial: Phase 1 Dose-escalation Study Evaluating the Safety, Pharmacodynamics, Pharmacokinetics, & Efficacy of GS-9901 in Subjects with Relapsed or Refractory Follicular Lymphoma, Marginal Zone Lymphoma, CLL/SLL

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with follicular lymphoma, marginal zone lymphoma, and CLL/SLL. The study sponsor is Gilead Sciences Inc., and the principal investigator at Weill Cornell is Richard Furman M.D.. For more information about the study, please call Amelyn Rodgriguez, RN at (212) 746-1362 or e-mail Amelyn at amr2017@med.cornell.edu.

Key Eligibility

  • Men and women age 18 and older.
  • Diagnosis of FL, MZL, or CLL/SLL.
  • Prior treatment with at least 1 chemotherapy or immunotherapy-based regimen.
  • Detailed eligibility reviewed when you contact the study team.

Study Details 

This clinical trial is for men and women with relapsed/refractory FL, MZL, or CLL/SLL.

GS-9901 is a second generation inhibitor of PI3K-delta which is critical for multiple signaling pathways that are hyperactive in B-cell malignancies and inflammation. The first generation PI3K-delta inhibitor idelalisib has been shown to induce durable disease control in patients with B-cell malignancies. Idelalisib as monotherapy or in combination with other agents (such as bendamustine, chlorambucil) and immunotherapy (rituximab, ofatumumab) has been shown to be tolerable and demonstrated clinical efficacy in clinical trials in patients with iNHL, CLL, and other hematological malignancies. This study will provide more information about whether GS-9901 can benefit subjects with B-cell malignancies in terms of efficacy and tolerability compared to first generation PI3K inhibitors.

Subjects will receive GS-9901 continuously throughout the study as long as they are responding to therapy and not experiencing unacceptable side effects. GS-9901 is administered orally once daily. After discontinuing treatment, follow-up information will be collected once every year for up to 5 years at clinic visits or through telephone calls.

Author: lymphomaprogram

Located on the Upper East Side of New York City, the Lymphoma Program at Weill Cornell Medical College/NewYork Presbyterian Hospital is internationally recognized for our efforts to enable patients with non-Hodgkin lymphoma, Hodgkin disease and related disorders to have the best possible clinical outcome, including cure when possible.

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