Oblimersen Sodium and Rituximab in Treating Patients With Recurrent B-cell Non-Hodgkin Lymphoma

Completed · Phase 2

Conditions studied: Cutaneous B-cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Intraocular Lymphoma, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Small Intestine Lymphoma, Splenic Marginal Zone Lymphoma, Testicular Lymphoma, Waldenström Macroglobulinemia

In brief

The goal of this clinical research study is to learn if the combination of oblimersen sodium and rituximab can help to shrink or slow the growth of the tumor in patients with B-cell non-Hodgkin's lymphoma who have not responded to earlier treatment. Oblimersen Sodium is an investigational drug. The safety of this combination treatment will also be studied

Key facts

Study ID

NCT00054639

Run by

National Cancer Institute (NCI)

People needed

48

Starts

2003-01-01

Expected to finish

2010-01-01

Last updated by the study team

2014-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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