NCT02914938

A Study of ME-401 in Subjects With CLL/SLL, FL, and B-cell Non Hodgkin's Lymphoma

A Three-Arm Study of ME-401 Monotherapy in Subjects With Relapsed/Refractory CLL, SLL, or FL, of ME-401 in Combination With Rituximab in Subjects With Relapsed/Refractory CLL/SLL or B-cell NHL, and of ME-401 in Combination With Zanubrutinib in Subjects With Relapsed/Refractory CLL/SLL or B-cell NHL

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: MEI Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Three-Arm Study of ME-401 in Subjects with Relapsed/Refractory CLL/SLL or FL, of ME-401 in Combination with Rituximab in Subjects with Relapsed/Refractory CLL/SLL or B-cell NHL, and of ME-401 in Combination with Zanubrutinib in Subjects with Relapsed/Refractory CLL/SLL or B-cell NHL

Detailed description

This is a three-arm study of ME-401 alone, of ME-401 in combination with rituximab, and of ME-401 in combination with zanubrutinib in subjects with relapsed/refractory CLL/SLL or B cell NHL. The 3 arms of the study will be conducted in parallel, with subject allocation to ME-401 alone, ME-401 plus rituximab, or ME-401 plus zanubrutinib based on disease type and availability of an open enrollment slot.

Conditions

• Chronic Lymphocytic Leukemia (CLL)
• Small Lymphocytic Lymphoma (SLL)
• Follicular Lymphoma (FL)
• Marginal Zone B Cell Lymphoma
• Diffuse Large B-cell Lymphoma (DLBCL)
• High Grade Non-Hodgkin's Lymphoma
• Mantle Cell Lymphoma (MCL)

Interventions

Type	Name	Description
DRUG	ME-401	60 mg
DRUG	Rituximab	IV infusion 375 mg/m2
DRUG	Zanubrutinib	80 and 160 mg bid

Timeline

• Start date: 2016-10-01
• Primary completion: 2023-03-29
• Completion: 2023-03-29
• First posted: 2016-09-26
• Last updated: 2023-05-09

Locations

24 sites across 2 countries: United States, Switzerland