Phase 2
N=48
Oblimersen Sodium and Rituximab in Treating Patients With Recurrent B-cell Non-Hodgkin Lymphoma
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
Bottom Line
View on ClinicalTrials.gov: NCT00054639 ↗Enrolled (actual)
48
Serious AEs
32.6%
Results posted
Feb 2011
Primary outcome: Primary: Number of Patients With Objective Response — 10; 8 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- oblimersen sodium (Biological); rituximab (Biological); laboratory biomarker analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Objective Response |
10; 8 | — |
Summary
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00054639). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.