Study of Mocetinostat in Selected Patients With Mutations of Acetyltransferase Genes in Relapsed and Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma
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|ClinicalTrials.gov Identifier: NCT02282358|
Recruitment Status : Active, not recruiting
First Posted : November 4, 2014
Last Update Posted : April 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Relapsed and Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma||Drug: Mocetinostat||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Phase II Study of Mocetinostat in Selected Patients With Mutations of Acetyltransferase Genes in Relapsed and Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma|
|Actual Study Start Date :||October 2014|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2020|
Patients who harbor mutations for CREBBP and/or EP300 will be started on mocetinostat 70 mg orally three times per week on a 28 day schedule in cycle 1. The dose will be escalated in cycle 2 to 90 mg orally three times per week on a 28 day schedule if there are no grade 3 or higher drug related toxicities. Therapy will continue until disease progression, intolerable toxicities or death.
- efficacy as defined by overall response [ Time Frame: 1 year ]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.
- event free survival [ Time Frame: 1 year ]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.
- duration of response [ Time Frame: 1 year ]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.
- toxicity according to the (NCI CTCAE) Version 4.0. [ Time Frame: 2 years ]will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02282358
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Andrew Zelenetz, MD, PhD||Memorial Sloan Kettering Cancer Center|