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TERMINATEDPHASE1/PHASE2

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

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

NCT02282358•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to learn if the study drug mocetinostat can slow the progression of cancer in people who have a mutation in CREBBP or EP300 in the genetic makeup of their cancer. The potential side effects of mocetinostat will also be studied.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient has provided a signed study Informed Consent Form prior to performance of any study related procedurePatient is ≥ 18 years of age
•Patient has histologically confirmed diagnosis of diffuse large B cell lymphoma or follicular lymphoma harboring mutations in CREBBP or EP300 with relapsed or refractory disease
•Patients with diffuse large B cell lymphoma must have received at least two prior therapies and have received, declined or be ineligible for autologous or allogeneic stem cell transplant.
•Patients with follicular lymphoma must have received at least two prior therapies.
•Patients with either diffuse large B cell lymphoma or follicular lymphoma will be allowed to enroll after receiving only 1 prior therapy if they are felt to not be a candidate for further systemic chemotherapy.
•Patient has at least one measurable lesion (≥ 2 cm) according to Cheson criteria \[45\]. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 - Patient has adequate bone marrow and organ function by:
•Absolute neutrophil count (ANC) ≥ 1.0 x 10\^9/L
•Platelets ≥ 75 x 10\^9/L (no platelet transfusion within past 14 days)
•Hemoglobin (Hgb) ≥ 9.0 g/dL (no RBC transfusion within past 14 days)
•International Normalized Ratio (INR) ≤ 1.5
+4 more criteria

Exclusion Criteria

•Patient has received previous treatment with HDAC inhibitors
•Patient has evidence of graft versus host disease (GVHD)
•Patient has active or history of central nervous system (CNS) disease
•Patient has impaired cardiac function including any of the following:
•Presence or history of pericardial effusion (definitions are provided in and/or pericarditis.
•Acute myocardial infarction, symptomatic angina pectoris ≤ 6 months prior to starting study drug
•Presence of congestive heart failure ≥ NYHA class 3
•QTc \> 480 ms on a screening ECG
•Screening LVEF \< 45% by echocardiography or MUGA
•Uncontrolled cardiac arrhythmia including uncontrolled atrial fibrillation/atrial flutter/sinus tachycardia, complete left bundle branch block, congenital long QT syndrome
+15 more criteria

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

October 1, 2014

Primary Completion Date

May 26, 2023

Completion Date

May 26, 2023

Last Updated

March 8, 2024

Enrollment

ACTUAL participants

Conditions

LymphomaRelapsed and RefractoryDiffuse Large B-Cell Lymphoma and Follicular Lymphoma

Interventions

Mocetinostat

DRUG

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 8, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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