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Clinical Trial Details

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Brief Title A Phase 1, Open-label Trial of Oral Azacitidine (CC-486) Plus RCHOP in Subjects With Large B-Cell Lymphoma or Follicular Lymphoma or Transformed Lymphoma
Official Title 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, GRADE 3B FOLLICULAR LYMPHOMA, OR TRANSFORMED LYMPHOMA
Principal Investigator Smith, Sonali
Brief Summary The goal of the study is to identify a dose and schedule of CC-486 that can be safely administered with R-CHOP. To evaluate the safety and maximum tolerated dose (MTD) or the maximal administered dose (MAD) of CC-486 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in subjects with high risk (IPI 3 or more) previously untreated DLBCL or Grade 3B FL, or transformed lymphoma. Also, to determine pharmacokinetics (PK) of CC-486 when administered alone and in combination with R-CHOP and to explore preliminary efficacy of CC-486 plus R-CHOP by 2007 International Working Group (IWG) criteria. Finally, to evaluate the pharmacodynamic (PD) effects of CC-486, to evaluate potential predictive/correlative biomarkers for DLBCL subgroups that are considered important and to explore cytidine deaminase (CDA) activity and polymorphisms.
Gender Both
Ages 18 Years
Enrollment 50
Accepts Healthy Volunteers No
Lead Sponsor Celgene CorporationIndustry
Collaborator
Study Design Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Phase Phase 1
Study Type Interventional
Contact Name
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Lymphoma, Large B-Cell, Diffuse
Detail for Health Professional (on clinicaltrials.gov)
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