A Phase 1B, Multi-Center, Open-Label Study of Novel Combinations of CC-122, CC-223, CC-292 and Rituximab in Diffuse Large B-cell Lymphoma

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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 subjects with relapsed/refractory DLBCL who have failed standard therapy.

Who is eligible to participate?

Inclusion Criteria: - Biopsy proven Diffuse large B-cell lymphoma (DLBCL) (including transformed low grade lymphoma) - Relapsed or refractory to prior standard treatment regimens - At least one site of measurable disease - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1. - Subjects 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. - Platelets ≥ 50 x 109/L without transfusion for 7 days. - 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 Exclusion Criteria: - Symptomatic central nervous system involvement. - Known symptomatic acute or chronic pancreatitis. - Persistent diarrhea or malabsorption despite medical management. - Peripheral neuropathy ≥ grade 2 - Impaired cardiac function or clinically significant cardiac diseases - Subjects with diabetes on active treatment (for subjects treated on CC-223 containing arms only) - Prior autologous stem cell transplant (ASCT) ≤ 3 months before first dose. - Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning. - Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks prior to starting study drugs, whichever is shorter. - Subjects who have undergone major surgery ≤ 2 weeks prior to starting study drugs. - Women who are pregnant or breast feeding. Adults of reproductive potential not willing to employ two forms of birth control. - Subjects with known HIV infection, chronic active hepatitis B or C virus (HBV/HCV) infection. - Subjects with treatment-related myelodysplastic syndrome. - History of concurrent second cancers requiring active, ongoing systemic treatment.

Last updated:

2/19/2014

NCT ID:

NCT02031419

IRB Number:

13-009098