This Phase 2 trial by the National Cancer Institute (NCI) examined whether the combination of oblimersen sodium (G3139, a bcl-2 antisense oligodeoxynucleotide, Genasense) and rituximab (Rituxan, Mabthera) could shrink or slow tumor growth in patients with B-cell non-Hodgkin's lymphoma (NHL) that had not responded to earlier treatment; oblimersen sodium is an investigational drug and the safety of the combination was also studied. Eligible patients had recurrent B-cell NHL with measurable disease, no anti-lymphoma therapy within the past 4 weeks, good performance status and adequate blood counts. The trial is completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Must have recurrent B-cell NHL and measurable disease * No anti-lymphoma therapy within the past 4 weeks * Must have a good performance status (less than or equal to 2 Zubrod, greater than or equal to 60 Karnofsky) * Absolute neutrophil count (ANC) greater than or equal to 1,000 * Platelets greater than or equal to 75,000 * Hemoglobin greater than or equal to 10 g/dL * Bilirubin less than or equal to 1.5 mg/dL * Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvate transaminase (SGPT) less than or equal to 2 times upper limit of laboratory normals * Alkaline phosphatase less than or equal to 2 times upper limit of laboratory normals * Serum creatinine less than or equal to 1.8 mg/dL * Must sign a consent form, and must have a life expectancy of greater than 12 weeks * No more than 3 prior chemotherapy regimens * Patients who are either Rituximab naive, have previously responded to Rituximab, or are refractory to Rituximab used alone or in combination with chemotherapy Exclusion Criteria: * Human immunodeficiency virus (HIV) positive * Active infection or history of opportunistic infections * Pregnant women and women of childbearing age who are not practicing adequate contraception; men who are not willing to use an effective method of contraception * History of second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for 5 or more years) * Active autoimmune disease * Other significant medical diseases * Patients with chronic lymphocytic leukemia (CLL) * Prior exposure to G3139