Category: Clinical Trials

New Clinical Trial: A Phase 1 Study to Assess Safety/Tolerability of REGN1979 & REGN2810 in Patients with B-Cell Malignancies

The Weill Cornell Medicine Lymphoma Program has recently opened a new clinical trial for men and women with B-cell non-Hodgkin lymphoma. The study sponsor is Regeneron Pharmaceuticals, Inc., and the principal investigator at Weill Cornell is Sarah Rutherford, M.D. For more information about the study, please call Rita Gazivoda, RN at 212-746-0702 or e-mail Rita at rig9021@med.cornell.edu.

Key Eligibility

  • Men and women age 18 and older with either B-cell non-Hodgkin lymphoma with active disease that is either refractory to or relapsed after most recent prior therapy for whom no standard of care options exist or documented Hodgkin lymphoma with active disease not responsive to prior therapy or relapsed after prior therapy for whom no standard of care options exist.
  • Detailed eligibility reviewed when you contact the study team.

Study Summary

This clinical trial is for men and women with lymphoma for whom no standard of care options exist. Currently available treatments for lymphoma are effective in some patients, however, other patients experience relapse or refractory disease following treatment. Therefore, there is a need to find more effective treatments when patients fail to respond to existing standard of care options. Patients will be administered REGN2810 intravenously every 2 weeks at a specified dose level. Patients will receive REGN2810 for a minimum of 12 doses (24 weeks) and up to a maximum of 24 doses (48 weeks). Upon completion of treatment, there will be a 24-week follow-up period. Patients will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects.

New Clinical Trial: Phase 2 Study Evaluating the Efficacy/Safety of PQR309 in Patients with Relapsed/Refractory Lymphoma

The Weill Cornell Medicine Lymphoma Program has recently opened a new clinical trial for men and women with relapsed/refractory lymphoma. The study sponsor is PIQUR Therapeutics AG, and the principal investigator at Weill Cornell is Lisa Roth M.D. For more information about the study, please call Catherine Babaran, RN at 212-746-2651 or e-mail Catherine at cmb9017@med.cornell.edu.

Key Eligibility

  • Men and women age 18 and older with histologically confirmed diagnosis of relapsed or refractory lymphoma who have received at least two prior lines of therapy including immuno-chemotherapy. Patients with relapsed chronic lymphoid leukemia (CLL) are eligible if they have received one or more prior lines of any approved standard therapy.
  • Detailed eligibility reviewed when you contact the study team.

Study Summary

This clinical trial is for men and women with relapsed or refractory lymphoma. Despite conventional therapies, such as chemotherapy and radiation therapy, the treatment of lymphomas remains challenging, with the disease relapsing in many patients, which is subsequently more difficult to treat. The main goal of this study is to investigate the efficacy of PQR309 in patients with relapsed or refractory lymphomas. This is an open-label, non-randomized, multicenter phase 2 study with a safety run-in evaluating efficacy and safety of PQR309 in patients with relapsed or refractory lymphoma. There will be a safety run-in phase with up to 12 patients treated with 60 or 80 milligrams every day and then a Phase 2 expansion phase conducted with the highest dose level considered to be safe.  Patients will take 60 mg or 80 mg PQR309 orally once daily and will continue treatment as long as they are responding to therapy and not experiencing unacceptable side effects.

Clinical Trial Participation May Improve Outcomes for Patients with Lymphoma

Picture1By Peter Martin, M.D.

Recently researchers from the Mayo Clinic presented data at the 2016 ASCO annual meeting suggesting that clinical trial participation might be associated with a survival benefit. The researchers used the Mayo Clinic Lymphoma Database to identify patients with relapsed Hodgkin lymphoma (HL), diffuse large B-cell lymphoma (DLBCL), or relapsed mantle cell lymphoma (MCL), and compared the characteristics and outcomes of those enrolled in clinical trials versus those who were eligible, but not enrolled in clinical trials. Between January 2001 and December 2014, 340 patients with DLBCL, 159 with MCL, and 115 patients with HL were identified. Over this same period 47 unique Phase 1-3 trials led to the FDA approval of 17 treatments.

94 of 340 (27%) DLBCL, 63 of 159 (41%) MCL and 66 of 115 (57%) HL patients were enrolled on a clinical trial at some point during therapy, with 38% of patients enrolled in more than 1 study. Researchers found that the median survival of patients treated in a clinical trial was roughly twice as long as patients not treated on a clinical trial in all 3 lymphoma subtypes. There are several possible sources of bias or confounding that might explain the difference, despite the researchers’ efforts to control for these variables. Clearly, more research in this areas is indicated. Nonetheless, the magnitude of benefit was striking and should be reassuring to patients considering clinical trial participation.