Clinical trial · Interventional
Oblimersen Sodium and Rituximab in Treating Patients With Recurrent B-cell Non-Hodgkin Lymphoma
A Phase II Study of G3139 (Bcl-2 Antisense) And Rituximab in Patients With Recurrent B-cell Non-Hodgkinâs Lymphomas
NCT00054639CI-TRIAL-00014702completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (21)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous B-cell Non-Hodgkin Lymphoma | Primary Cutaneous B-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | ALIAS | 0.90 |
| Intraocular Lymphoma | Primary Intraocular Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Nodal Marginal Zone B-cell Lymphoma | Nodal Marginal Zone Lymphoma | ALIAS | 0.90 |
| Recurrent Adult Burkitt Lymphoma | Adult Burkitt Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Adult Diffuse Large Cell Lymphoma | — | UNRESOLVED | — |
| Recurrent Adult Diffuse Mixed Cell Lymphoma | — | UNRESOLVED | — |
| Recurrent Adult Diffuse Small Cleaved Cell Lymphoma | Non-Hodgkin Lymphoma |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| oblimersen sodium | Biological | — | UNRESOLVED |
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (oblimersen sodium and monoclonal antibody therapy)
- description
- 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.
- interventionNames
- Biological: oblimersen sodium
- Biological: rituximab
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Number of Patients With Objective Response
- timeFrame
- 2 months following study treatment
- description
- Efficacy as measured by objective response complete (CR) and partial (PR) response rates at 2 months following study treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.