ME-401 and R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diffuse Large B Cell 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
This study is a multi-institution, open-label, phase I/II study designed to evaluate the safety and efficacy of R-CHOP + ME-401 for participants with newly diagnosed DLBCL. Objectives for the phase I portion of this study are as follows: Primary objectives: To determine the recommended phase 2 dose ...
This study is a multi-institution, open-label, phase I/II study designed to evaluate the safety and efficacy of R-CHOP + ME-401 for participants with newly diagnosed DLBCL. Objectives for the phase I portion of this study are as follows: Primary objectives: To determine the recommended phase 2 dose (RP2D) of ME-401in combination with R-CHOP for participants with newly diagnosed DLBCL. To describe tolerability of ME-401 in combination with R-CHOP for participants with newly diagnosed DLBCL. Objectives for the phase II portion of this study are as follows: To estimate the clinical activity of ME-401 in combination with R-CHOP in participants with newly diagnosed DLBCL, as measured by 1 year PFS rate To estimate the response rates (complete and partial remission),duration of response (DOR), time to progression (TTP), and overall survival (OS) with ME-401 plus R-CHOP. To characterize treatment-related AEs in participants treated with ME-401 plus R-CHOP.
Tracking Information
- NCT #
- NCT04517435
- Collaborators
- Case Comprehensive Cancer Center
- Investigators
- Principal Investigator: Deepa Jagadeesh, MD, MPH Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
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