Trial Outcomes & Findings for Study of Mocetinostat in Selected Patients With Mutations of Acetyltransferase Genes in Relapsed and Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma (NCT NCT02282358)

Study of Mocetinostat in Selected Patients With Mutations of Acetyltransferase Genes in Relapsed and Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma

as defined by overall response rate of Mocetinostat at one year in patients with relapsed/refractory DLBCL and FL who have inactivating mutations of acetyltransferase genes. Response will be measured according to the 2007 revised Cheson criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=50% decrease in sum of the product of the diameters (SPD) of up to 6 dominant lesions identified at baseline; Overall Response (OR) = CR + PR.

defined as time from the date of treatment start to the date of the first documented progressive disease (PD) or death due to any cause) rate using mocetinostat in this selected population will be estimated by the Kaplan-Meier method. Relapsed disease/progressive disease is defined as at least 50% increase of target measurable nodal lesions

is defined as the time from the date of first occurrence of CR or PR whichever is recorded first to the date of the first objectively documented progressive disease (PD) or death due to any cause. The duration of response will be assessed based on the sub-cohort of patients who showed responses also using Kaplan-Meier.

will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0.