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Clinical Trial 18165
Interventions:Adriamycin (doxorubicin); CC-486 (Azacitidine (Oral)); Rituxan (rituximab); Vincristine; cyclophosphamide; cytoxan (cyclophosphamide); doxorubicin; prednisone; rituximab
Study Type: Treatment
Phase of Study: Phase I
- Julio Chavez
A Phase 1, Open-Label, Multicenter Trial of Oral Azacitidine (CC-486) Plus R-Chop in Subjects with IPI 2 or More Previously Untreated Diffuse Large B-Cell Lymphoma or Grade 3B Follicular Lymphoma, or Transformed Lymphoma
The purpose of this study is to look at the safety of oral azacitidine when combined with R- CHOP (drugs normally used in treating Diffuse large B-cell lymphoma or Grade 3B follicular lymphoma). The other purposes of this study are to understand how the human body takes in and removes oral azacitidine when given with R-CHOP, if the Diffuse large B-cell lymphoma or Grade 3B follicular lymphoma tumor size decreases, and to look into the effects the drug can have on the human body.
Primary Objective: The primary objective of the study is to evaluate the safety and to determine the MTD or the maximal administered dose (MAD) of CC-486 in combination with R-CHOP in subjects with IPI>=2 or previously untreated DLBCL, Grade 3B FL, or transformed lymphoma. The MAD is the highest recorded dose administered to a subject if the MTD is not reached (Le Tourneau, 2010). Secondary Objectives: The secondary objectives of the study are: To determine pharmacokinetics (PK) of CC-486 when administered alone and in combination with R-CHOP. To explore preliminary efficacy of CC-486 plus R-CHOP by 2007 International Working Group (IWG) criteria. Exploratory Objectives: The exploratory objectives of the study are, by means of a biomarker program: To evaluate the pharmacodynamic effects of CC-486: - Confirm that low doses of CC-486 can reduce global DNA methylation (enhanced reduced representation bisulfite [ERRBS]) without DNA damage (phospho 2AX). - Explore/confirm MOA hypothesis based on reversal of hypermethylation of genes controlling the « SWING » phenotype restoring sensitivity to cytotoxic agents (MassArray). To evaluate potential predictive/correlative biomarkers for DLBCL subgroups that are considered important. To explore cytidine deaminase (CDA) activity and polymorphisms.