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
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?
- 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
- 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.