Oblimersen Sodium and Rituximab in Treating Patients With Recurrent B-cell Non-Hodgkin Lymphoma
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ClinicalTrials.gov Identifier: NCT00054639 |
Recruitment Status :
Completed
First Posted : February 6, 2003
Results First Posted : February 21, 2011
Last Update Posted : May 28, 2014
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Condition or disease | Intervention/treatment | Phase |
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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 | Biological: oblimersen sodium Biological: rituximab Other: laboratory biomarker analysis | Phase 2 |
PRIMARY OBJECTIVES:
I. To determine the therapeutic efficacy and toxicity of G3139 (oblimersen sodium) and Rituximab in patients with recurrent B-cell NHL.
SECONDARY OBJECTIVES:
I. To determine the effect of G3139 and Rituximab on the level of Bcl-2 expression.
II. The secondary objective of this study is to evaluate the effect of G3139 and Rituximab on Bcl-2 protein gene expression.
OUTLINE:
Patients receive oblimersen sodium intravenously (IV) continuously on days 1-7, 15-21, and 29-35 and rituximab IV over 4-6 hours on days 3, 8, 15, 22, 29, and 36. Patients achieving stable disease or objective response may receive one additional course of treatment.
After completion of study treatment, patients are followed up every 3 months.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 48 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study of G3139 (Bcl-2 Antisense) And Rituximab in Patients With Recurrent B-cell Non-Hodgkinâs Lymphomas |
Study Start Date : | January 2003 |
Actual Primary Completion Date : | January 2010 |
Actual Study Completion Date : | January 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment (oblimersen sodium and monoclonal antibody therapy)
Patients receive oblimersen sodium IV continuously on days 1-7, 15-21, and 29-35 and rituximab IV over 4-6 hours on days 3, 8, 15, 22, 29, and 36. Patients achieving stable disease or objective response may receive one additional course of treatment.
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Biological: oblimersen sodium
Given IV
Other Names:
Biological: rituximab Given IV
Other Names:
Other: laboratory biomarker analysis Correlative studies |
- Number of Patients With Objective Response [ Time Frame: 2 months following study treatment ]Efficacy as measured by objective response complete (CR) and partial (PR) response rates at 2 months following study treatment

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00054639
United States, Texas | |
M D Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Barbara Pro | M.D. Anderson Cancer Center |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00054639 |
Obsolete Identifiers: | NCT01654952 |
Other Study ID Numbers: |
NCI-2011-00617 ID02-148 N01CM17003 ( U.S. NIH Grant/Contract ) N01CM62202 ( U.S. NIH Grant/Contract ) N01CM17107 ( U.S. NIH Grant/Contract ) N01CM62203 ( U.S. NIH Grant/Contract ) |
First Posted: | February 6, 2003 Key Record Dates |
Results First Posted: | February 21, 2011 |
Last Update Posted: | May 28, 2014 |
Last Verified: | March 2013 |
Burkitt Lymphoma Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Mantle-Cell Lymphoma, B-Cell, Marginal Zone Leukemia, Lymphocytic, Chronic, B-Cell Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Plasmablastic Lymphoma Waldenstrom Macroglobulinemia Lymphomatoid Granulomatosis Intraocular Lymphoma |
Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Leukemia, Lymphoid Leukemia Epstein-Barr Virus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases Tumor Virus Infections Neoplasms, Plasma Cell |