In this video from OncLive, Director of the CLL Research Center, Richard R. Furman, M.D. discusses infusion reactions for chronic lymphocytic leukemia (CLL) patients treated with anti-CD20 antibodies, including rituximab, obinutuzumab, and ofatumumab.
Tag: Richard Furman MD
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.
ASCO 2015: Safety of Idelalisib in B-cell Malignancies: Integrated Analysis of Eight Clinical Trials
Idelalisib is a first in class, selective, oral inhibitor of PI3Kδ approved by the FDA for the treatment of chronic lymphocytic leukemia (CLL) in combination with rituximab and as a monotherapy for patients with follicular lymphoma, who have received at least two prior systemic therapies. A recent study sought to analyze the safety profile of idelalisib in 760 subjects with heavily pre-treated and relapsed CLL, non-Hodgkin lymphoma, and other B-cell malignancies, who received idelalisib alone or as part of a combination therapy. Side effects leading to changes in dosing included transaminase elevations (13%), diarrhea/colitis (11%), and rash. Side effects leading to discontinuation of treatment were rare. Patient’s whose dose was interrupted due to adverse events were frequently able to tolerate dosing upon re-challenge. These data demonstrate that idelalisib was well tolerated in patients as a monotherapy or in combination.

