Tag: relapsed/refractory lymphoma

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.

New Clinical Trial: Phase 3 Study to Compare Rituximab + Lenalidomide to Rituximab + Placebo in Patients with Relapsed/Refractory Indolent Lymphoma

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with relapsed/refractory indolent lymphoma. The study sponsor is the Celgene Corporation, and the principal investigator at Weill Cornell is Dr. John Leonard. 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
  • Histologically confirmed MZL or Grade 1,2, or 3a FL
  • Relapsed, refractory, or progressive disease after treatment with systemic therapy, and must be rituximab-sensitive if had received rituximab or R-chemo regimen therapy
  • Detailed eligibility reviewed when you contact the study team

Study Details 

This phase 3 multicenter, double-blind, randomized study is designed to evaluate the efficacy and safety of rituximab plus lenalidomide versus rituximab plus placebo. Subjects must have an investigator-assessed diagnosis of relapsed/refractory indolent lymphoma, defined in this clinical trial as Grade 1, 2 or 3a follicular lymphoma or marginal zone lymphoma, must have been previously treated for their lymphoma with systemic therapy (chemotherapy, immunotherapy, or chemo immunotherapy), must be refractory to or have relapsed after their last treatment, may be rituximab-naïve or rituximab-sensitive, must have at least one measurable lesion by computed axial tomography (CT) or magnetic resonance imaging (MRI) scan, and must have adequate bone marrow function, liver function and renal function.

The study is divided into the Screening Period (up to 28 days), Treatment Period (up to 12 28-day cycles), and Follow-up Period. Approximately 350 subjects are planned to be randomized with 5 subjects at WCMC. Each patient will receive rituximab weekly during cycle 1 and then on day 1 of cycles 2-5. Depending on randomization, subjects will also receive either lenalidomide or placebo on days 1-21 of cycles 1-12.

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