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Clinical Trial Summary

This phase Ib/II trial is aimed at studying the combination of a drug named Selinexor (selective inhibitor of nuclear export) in combination with standard therapy for B cell Non-Hodgkin's lymphoma called R-CHOP. The investigators will establish maximum tolerated dose of Selinexor in combination with RCHOP and also study the efficacy of this combination for therapy of B cell Non-Hodgkin's lymphoma. Giving Selinexor plus chemotherapy may work better in treating patients with B cell non-Hodgkin lymphoma.


Clinical Trial Description

The study will be done in two phases namely phase 1B and phase 2.

In the phase 1B component the investigators intend to enroll patients in a 3+3 dose escalation design. Newly diagnosed indolent and diffuse large cell lymphomas as well as relapsed/refractory indolent B cell lymphomas are eligible for enrollment in the phase 1 component. The primary end-point for this component would be to establish the recommended phase 2 dose (RP2D) for Selinexor in combination with standard dose RCHOP chemotherapy.

In the phase 2 part of the study the investigators will use recommended phase 2 dose of Selinexor plus standard dose RCHOP combination to treat newly diagnosed DLBCL patients with the primary end-point being 2 year Progression free survival.

Maintenance Phase: Patients with Follicular Lymphoma and Diffuse Large B cell lymphoma able to achieve PR or better at the end of therapy scan will be put on maintenance Selinexor for a total of one year. The dose of Selinexor in the maintenance phase would be similar to the last dose used for that particular patient in the treatment phase 1 or 2. ;


Study Design


Related Conditions & MeSH terms

  • Diffuse Large B-Cell Lymphoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Mantle-Cell
  • Lymphoma, Non-Hodgkin
  • Recurrent B-Cell Non-Hodgkin Lymphoma
  • Recurrent Extranodal Marginal Zone Lymphoma
  • Recurrent Follicular Lymphoma
  • Recurrent Indolent Adult Non-Hodgkin Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Waldenstrom Macroglobulinemia
  • Refractory B-Cell Non-Hodgkin Lymphoma
  • Refractory Extranodal Marginal Zone Lymphoma
  • Refractory Follicular Lymphoma
  • Refractory Mantle Cell Lymphoma
  • Stage III Non-Hodgkin Lymphoma
  • Stage IV Non-Hodgkin Lymphoma
  • Transformed Recurrent Non-Hodgkin Lymphoma
  • Waldenstrom Macroglobulinemia

NCT number NCT03147885
Study type Interventional
Source Barbara Ann Karmanos Cancer Institute
Contact Clinical Trials Office-Call Center
Phone 800-527-6266
Email seymoure@karmanos.org
Status Recruiting
Phase Phase 1/Phase 2
Start date June 20, 2017
Completion date December 28, 2018

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