Selinexor Plus Combination Chemotherapy in Treating Patients With Advanced B Cell Non-Hodgkin Lymphoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Refractory Extranodal Marginal Zone Lymphoma
- Diffuse Large B Cell Lymphoma
- Recurrent B-Cell Non-Hodgkin Lymphoma
- Recurrent Extranodal Marginal Zone Lymphoma
- Recurrent Follicular Lymphoma
- Stage III Non-Hodgkin Lymphoma
- Recurrent Indolent Adult Non-Hodgkin Lymphoma
- Recurrent Mantle Cell Lymphoma
- Recurrent Marginal Zone Lymphoma
- Recurrent Waldenstrom Macroglobulinemia
- Refractory Mantle Cell Lymphoma
- Stage IV Non-Hodgkin Lymphoma
- Transformed Recurrent Non-Hodgkin Lymphoma
- Refractory B-Cell Non-Hodgkin 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