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Epigenetic Modulation in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

2014-07-23 21:12:45 | BioPortfolio

Summary

The purpose of this study is evaluate the response, safety and tolerability in subjects receiving the investigational drugs (RAD001 and LBH589), when each investigational drug is given by itself and when they are taken together.

Description

This will be a prospective, non-randomized, un-blinded phase 2 efficacy trial using an mTOR inhibitor and a histone deacetylase (HDAC) inhibitor for epigenetic targeted therapies. There will be two parts to the trial.

Part 1: Sequential single agent therapy with RAD001 and LBH589 (Part 1 a & 1b). Each agent will be given for up to six 28-day cycles. There will be a 1-6 week 'washout' period between stopping and starting each agent, unless rapid progression suggests holding therapy would not be in the patient's best interest.

There will be no washout period between Part 1 and Part 2. Part 2 will follow a standard 3+3 dose escalation design to determine dose limiting toxicities and maximum tolerated dose.

Treatment will be administered on an outpatient basis. Patients will be followed for up to 2 years after completion of therapy or until progression of disease or death. Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event and will continue to be followed for 2 years or until progression of disease or death.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Diffuse Large B-cell Lymphoma

Intervention

RAD001, LBH589, RAD001 and LBH589 as a doublet

Location

Duke University Medical Center
Durham
North Carolina
United States
27710

Status

Recruiting

Source

Duke University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:12:45-0400

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Medical and Biotech [MESH] Definitions

Malignant lymphoma composed of large B lymphoid cells whose nuclear size can exceed normal macrophage nuclei, or more than twice the size of a normal lymphocyte. The pattern is predominantly diffuse. Most of these lymphomas represent the malignant counterpart of B-lymphocytes at midstage in the process of differentiation.

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