Tag: follicular lymphoma

New Clinical Trial: A Phase 1/2 Proof of Concept Study of the Combination of ACP-196 & ACP-319 in Subjects with B-cell Malignancies

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with previously treated B-cell malignancies. The study sponsor is Acerta Pharmaceuticals, 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 non-GCB DLBCL, MCL, FL, WM, or CLL/SLL.
  • At least one prior therapy meeting the criteria for relevant disease type.
  • Detailed eligibility reviewed when you contact the study team.

Study Summary

This clinical trial is for men and women with previously treated B-cell malignancies.

In recent years, clinical trials with small molecule inhibitors of Btk and PI3K-delta have produced high response rates with few drug-related toxicities in subjects with B-cell malignancies. Specifically, ibrutinib and idelalisib have shown very encouraging results and each have gained FDA approval in specific patient populations, however, some subjects develop progressive disease or resistance after a period of time on these treatments. This study aims to assess the clinical potential and safety of a dual inhibition approach by combining ACP-196, a second generation Btk inhibitor, with ACP-319, a second generation PI3K inhibitor. The study will provide more information about whether this targeted combination therapy can benefit subjects with B-cell malignancies over single agent therapies or traditional chemotherapy combinations without an increase in toxicity.

Subjects will receive ACP-196 and ACP-319 continuously throughout the study as long as they are responding to therapy and not experiencing unacceptable side effects. Both ACP-196 and ACP-319 are administered orally twice daily. After discontinuing treatment, subjects will remain in long-term follow-up until they receive their next therapy.

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.

Dr. John Leonard Discusses Use of Lenalidomide + Rituximab in Patients with Recurrent Follicular Lymphoma

In this video clip from OncLive Lymphoma Program Director, John Leonard, MD discusses the combination of lenalidomide and rituximab in patients with recurrent follicular lymphoma.