Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Recurrent B-Cell Non-Hodgkin Lymphoma
  • Diffuse Large B Cell Lymphoma
  • Recurrent Extranodal Marginal Zone Lymphoma
  • Transformed Recurrent Non-Hodgkin Lymphoma
  • Recurrent Follicular Lymphoma
  • Recurrent Indolent Adult Non-Hodgkin Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Stage III Non-Hodgkin Lymphoma
  • Refractory Mantle Cell Lymphoma
  • Stage IV Non-Hodgkin Lymphoma
  • Recurrent Waldenstrom Macroglobulinemia
  • Refractory B-Cell Non-Hodgkin Lymphoma
  • Refractory Extranodal Marginal Zone Lymphoma
  • Refractory Follicular Lymphoma
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT03147885
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Dipenkumar Modi, M.D. Barbara Ann Karmanos Cancer Institute