Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of CUDC-907 With and Without Rituximab in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma, Including Patients With MYC Alterations

Investigator: Swaminathan Iyer, MD

Study Coordinator: Karen Woodard

Status: Active Number: NCT02674750

Phone: 713.441.4332

Protocol Number: Pro00014794


This is a Phase 2, open-label, multicenter trial designed to evaluate the efficacy and safety of CUDC-907 monotherapy and R-907 (rituximab in combination with CUDC-907) in subjects 18 years and older with Relapsed/Refractory (RR) MYC-altered Diffuse Large B-Cell Lymphoma (DLBCL). Detailed Description: Patients with RR DLBCL will be eligible for treatment with CUDC-907 or R-907, as long as they have tumor tissue available that can be tested for MYC-altered disease based on one of the following: •Fresh tumor tissue obtained from biopsy accessible lesions , or •Archived tumor tissue (most recent available) Subjects will be required to submit archival tumor samples (most recent available) or fresh tumor samples for central FISH and IHC testing. Subjects whose tumors have been previously characterized as MYC-altered are strongly encouraged to enter the study. For subjects who enter the study with unconfirmed MYC-altered disease, fresh tumor samples are preferred.
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