Tag: cancer clinical trials

New Clinical Trial: Phase 2B Open-label, Randomized Two-arm Study of Selinexor with Low Dose Dexamethasone in Patients with Relapsed/Refractory DLBCL

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The study sponsor is Karyopharm, and the principal investigator at Weill Cornell is Peter Martin, 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
  • Pathologically confirmed DLBCL whose disease is relapsed and/or refractory with documented evidence of disease progression after the most recently administered chemotherapy regimen and who in the opinion of the investigator are not candidates for high-dose chemotherapy with stem cell rescue
  • Patients must have received at least 2 but no more than 4 prior multi-agent therapies
  • Detailed eligibility reviewed when you contact the study team

Study Details

This clinical trial is for men and women with Diffuse Large B-Cell Lymphoma (DLBCL) and were previously treated for this disease.

For patients who are not cured with front-line therapy, DLBCL is a very difficult disease to manage with only limited treatment options. Selinexor has demonstrated anti-tumor activity in heavily pretreated patients with various subtypes of DLBCL. This study is designed to confirm selinexor activity with relapse and/or refractory DLBCL in patients who have had at least two but no more than four prior multi-agent therapies and are not eligible for high dose chemotherapy with stem cell rescue at the time of study entry.

This is a randomized, two-arm, multicenter, open-label Phase 2b study of the selinexor high (100 mg) and selinexor low (60 mg) doses with low dose dexamethasone given orally to patients with relapsed/refractory DLBCL who have no therapeutic options of demonstrated clinical benefit. Two hundred patients (100 per arm) with relapsed/refractory DLBCL who meet eligibility criteria will be enrolled and randomized in a 1:1 ratio of high (100 mg) to low (60 mg) selinexor doses.

Palbociclib for Patients with Previously Treated Mantle Cell Lymphoma

Earlier this week the FDA granted accelerated approval to palbociclib for the treatment of advanced (metastatic) breast cancer in combination with letrozole. Palbociclib selectively inhibits cyclin-dependent kinase 4 (CDK4) and 6 (CDK6), thereby suppressing tumor cell proliferation.

Over the past decade, researchers at Weill Cornell have led investigations of palbociclib in multiple myeloma and mantle cell lymphoma, including an ongoing phase I trial of palbociclib in combination with ibrutinib for patients with previously treated mantle cell lymphoma. Additional trials are planned.

Please look to this space for further updates concerning palbociclib for lymphoma patients. A full listing of available clinical trials can be found on our clinical trials page.

Research Collaborators at WCMC

Visit our research collaborators page to learn more about some of the Lymphoma Program’s close internal research collaborators at Weill Cornell Medical College.