Clinical Trials

Inclusion Criteria:

• Is ≥ 18 years of age at the time of signing the informed consent form (ICF).
• Participant has histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated, a-BCL according to 2016 WHO classification.
• Participant has poor-risk disease defined as International Prognostic Index (IPI) score ≥ 3 (high-intermediate or high-risk).
• Participants must have measurable disease defined by at least one FDG-avid lesion for FDGavid subtype and one bi-dimensionally measurable (> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification (Cheson, 2014).
• Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Participants must have the following laboratory values:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L or ≥ 1.0 x 10^9/L in case of documented bone marrow involvement (> 50% or tumor cells), without growth factor support for 7 days (14 days if peg-G-CSF);
  • Hemoglobin (Hb) ≥ 8 g/dL;
  • Platelets (PLT) ≥ 75 x 10^9/L or ≥ 50 x 1^09/L in case of documented bone marrow involvement (> 50% or tumor cells), without transfusion for 7 days;
  • Aspartate aminotransferase / serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase / serum glutamate pyruvic transaminase (ALT/SGPT) ≤ 2.5 x upper limit of normal (ULN). In the case of documented liver involvement by lymphoma, ALT/SGPT and AST/SGOT must be ≤ 5.0 x ULN;
  • Serum total bilirubin ≤ 2.0 mg/dL except in cases of Gilbert syndrome, then ≤ 5.0 mg/dl;
  • Estimated serum creatinine clearance of ≥ 50 mL/min.
• All participants must:
  • Have an understanding that the study drug could have a potential teratogenic risk;
  • Agree to follow all requirements defined in the Pregnancy Prevention Program for CC-220 or CC-99282 Pregnancy Prevention Plan for Participants in Clinical trials.
• Females of childbearing potential (FCBP) must:
  • Have two negative pregnancy tests as verified by the investigator prior to starting study therapy.
• Male participants must:
  • Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study.

Exclusion Criteria:

• Any significant medical condition, active infection (including SARS-CoV-2 suspected or confirmed), laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
• Any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study.
• Any other subtype of lymphoma.
• Documented or suspected CNS involvement by lymphoma.
• Persistent diarrhea or malabsorption ≥ Grade 2 (NCI CTCAE v5.0), despite medical management.
• Peripheral neuropathy ≥ Grade 2 (NCI CTCAE v5.0).
• Chronic systemic immunosuppressive therapy or corticosteroids.
• Impaired cardiac function or clinically significant cardiac disease, including any of the following:
  • Left ventricular ejection fraction (LVEF) < 45% as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).
• Major surgery ≤ 2 weeks prior to starting CC-220 or CC-99282; participant must have recovered from any clinically significant effects of recent surgery.
• Any condition causing inability to swallow tablets.
• Known seropositivity for or active viral infection with human immunodeficiency virus (HIV).
• Known chronic active hepatitis B (hepatitis B surface antigen [HBsAg] positive and/or hepatitis B core antibody [anti-HBc] positive with viral DNA positive) or C (positive serology requiring treatment and/or with evidence of liver damage) infection.
• History of other malignancy, unless being free of the disease for ≥ 3 years; exceptions to the ≥ 3-year time limit include history of the following:
  • Localized nonmelanoma skin cancer;
  • Carcinoma in situ of the cervix;
  • Carcinoma in situ of the breast;
  • Incidental histologic finding of prostate cancer (T1a or T1b as per Tumor Node Metastasis [TNM] staging system) or prostate cancer that has been treated with curative intent.
• Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients of rituximab.
• Known hypersensitivity to any component of CHOP regimen.
• Known allergy to thalidomide, pomalidomide, or lenalidomide.

Eligibility last updated 8/20/21. Questions regarding updates should be directed to the study team contact.