Novel Combinations of CC-122, CC-223, CC-292, and Rituximab in Diffuse Large B-cell Lymphoma and Follicular Lymphoma

Trial details

Who runs it

Celgene

Trial code

NCT02031419

Record updated

18 January 2024

Original description

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 LymphomaRead full original descriptionShow less

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 and Follicular Lymphoma

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

Inclusion: Men and women, 18 years or older, with histologically or cytologically-confirmed either:; Chemo-refractory DLBCL (including transformed low grade lymphoma); Lenalidomide naïve; relapsed or refractory CD20-positive follicular lymphoma (Grade 1, 2, or 3a) following at least one prior standard systemic treatment regimen including systemic chemo-, immune-; or chemo-immunotherapy and at least one prior line of salvage therapy with no prior exposure to lenalidomide, or double-refractory FL participants with no prior exposure to lenalidomide (FL-1 cohort); Lenalidomide exposed: relapsed or refractory CD20-positive follicular lymphoma (Grade 1, 2, or 3a) previously treated with at least two cycles of lenalidomide-containing regimen (FL-2 cohort), either as a single agent or in combination; 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); Males enrolled into treatment arms receiving CC-122 must: Agree to abstain from donating sperm while taking IP and for at least 95 days following discontinuation of IP.

Exclusion: 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; Participants who have undergone major surgery ≤ 2 weeks prior to starting study drugs; History of concurrent second cancers requiring active, ongoing systemic treatment; Prior treatment with a dual mTORC1/mTORC2 inhibitor (CC-223 arms only) or BTK inhibitor (PCI-32765) (CC-292 arms only). [Prior treatment with rapamycin analogues, PI3K or AKT inhibitors, lenalidomide and rituximab are allowed]; Impaired cardiac function or clinically significant cardiac diseases; Participants with diabetes on active treatment (for participants treated on CC-223 containing arms only); Participants with known HIV infection, chronic active hepatitis B or C virus (HBV/HCV) infection; Participants with treatment-related myelodysplastic syndrome; Symptomatic central nervous system involvement; Known symptomatic acute or chronic pancreatitis; Persistent diarrhea or malabsorption despite medical management; Peripheral neuropathy ≥ grade 2; Women who are pregnant or breast feeding. Adults of reproductive potential not willing to employ two forms of birth control.

ClinicalTrials.gov NCT02031419