NCT04517435

ME-401 and R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma

An Open-Label, Phase I/II Study of ME-401 and R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Deepa Jagadeesh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to evaluate if ME-401 can improve the treatment of patients with diffuse large b-celllymphoma (DLBCL). Many patients with DLBCL that are treated with the standard of care (R-CHOP) are cured. However, a little less than half of patients will have their cancer come back despite being treated. Once DLBCL comes back, it is much harder to treat and treatment is much more aggressive. This study will combine ME-401 with R-CHOP. There are 2 parts to this study: part1 referred to as phase I and part 2 referred to as phase 2. The goal of the phase I study is to find the safest dose to give patients in combination with R-CHOP. The goal of the phase 2 study is to use the safest dose (found in phase 1) in combination with R-CHOP to see if it decreases the rate of cancer coming back after it is treated.

Detailed 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 (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.

Conditions

• Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	ME-401	ME-401 (60 mg) will be given by mouth every 21 days for 6 cycles on days 1-4 (dose level 1) OR days 1-7 (dose level 2) of a 21 day cycle. Dose escalation will be performed in a standard 3+3 design
DRUG	Rituximab	375 mg/m2 IV/subcutaneous rituximab day 1 of 21-day cycle. First dose of rituximab will be given IV and subsequent doses can be either IV or SQ based on institutional guidelines.
DRUG	Cyclophosphamide	750 mg/m2 IV Cyclophosphamide day 1 of 21-day cycle
DRUG	Doxorubicin	50 mg/m2 IV Doxorubicin day 1 of 21-day cycle
DRUG	Vincristine	1.4 mg/m2 (max 2 mg) IV Vincristine
DRUG	Prednisone	100mg PO Prednisone Days 1-5 of 21-day cycle

Timeline

• Start date: 2021-04-28
• Primary completion: 2023-05-17
• Completion: 2023-05-17
• First posted: 2020-08-18
• Last updated: 2025-02-07
• Results posted: 2025-02-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study