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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.
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Diffuse Large B-cell Lymphoma
RAD001, LBH589, RAD001 and LBH589 as a doublet
Duke University Medical Center
Published on BioPortfolio: 2014-07-23T21:12:45-0400
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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.
B-cell lymphoid tumors that occur in association with AIDS. Patients often present with an advanced stage of disease and highly malignant subtypes including BURKITT LYMPHOMA; IMMUNOBLASTIC LARGE-CELL LYMPHOMA; PRIMARY EFFUSION LYMPHOMA; and DIFFUSE, LARGE B-CELL, LYMPHOMA. The tumors are often disseminated in unusual extranodal sites and chromosomal abnormalities are frequently present. It is likely that polyclonal B-cell lymphoproliferation in AIDS is a complex result of EBV infection, HIV antigenic stimulation, and T-cell-dependent HIV activation.
A human cell line established from a diffuse histiocytic lymphoma (HISTIOCYTIC LYMPHOMA, DIFFUSE) and displaying many monocytic characteristics. It serves as an in vitro model for MONOCYTE and MACROPHAGE differentiation.
A disease of elderly men characterized by large osteophytes that bridge vertebrae and ossification of ligaments and tendon insertions.
A group of malignant lymphomas thought to derive from peripheral T-lymphocytes in lymph nodes and other nonlymphoid sites. They include a broad spectrum of lymphocyte morphology, but in all instances express T-cell markers admixed with epithelioid histiocytes, plasma cells, and eosinophils. Although markedly similar to large-cell immunoblastic lymphoma (LYMPHOMA, LARGE-CELL, IMMUNOBLASTIC), this group's unique features warrant separate treatment.
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
The development and maintenance of an organism is orchestrated by a set of chemical reactions that switch parts of the genome off and on at strategic times and locations. Epigenetics is the study of these reactions and the factors that influence them. ...