Status and phase
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About
First study, at multiple clinical centers, exploring the effects of different combinations of compounds (CC-122, CC-223 ,CC-292 and rituximab) to treat Diffuse Large B Cell Lymphoma (DLBCL) and Follicular Lymphoma
Full description
Study CC-122-DLBCL-001 is a Phase 1b dose escalation and expansion clinical study of CC 122, CC-223 and CC-292 administered orally as doublets with or without rituximab, in participants with relapsed/refractory DLBCL who have failed standard therapy.
In expansion phase, selected combination will be administered to lenalidomide naïve FL participants and lenalidomide exposed FL participants in addition to relapsed/refractory DLBCL participants.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Men and women, 18 years or older, with histologically or cytologically-confirmed either:
At least one site of measurable disease
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
Participants must have the following laboratory values:
Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L or ≥ 1.0 x 109/L (with bone marrow involvement with DLBCL)
Hemoglobin (Hgb) ≥ 8 g/dL.
Potassium within normal limits
Asparate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) and Alanine Aminotransferase/Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) ≤ 2.5 x Upper Limit of Normal (ULN) or ≤ 5.0 X ULN if liver tumor is present.
Serum bilirubin ≤ 1.5 x ULN.
Estimated serum creatinine clearance of ≥ 50 mL/min
Participants must have the following laboratory values:
Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L without growth factor support for 7 days (14 days if participants received pegfilgrastim).
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
174 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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