At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 48 enrolled
Drug / intervention
oblimersen sodium +2 morebiological
Likely dose
Oblimersen sodium IV and rituximab IV (specific doses not stated)AI-extracted
Key inclusion· 6
- ✓Recurrent B-cell NHL with measurable disease
- ✓No anti-lymphoma therapy within 4 weeks prior
- ✓Performance status Zubrod ≤2 or Karnofsky ≥60
- ✓No more than 3 prior chemotherapy regimens
Key exclusion· 6
- ✕HIV positive
- ✕Active infection or history of opportunistic infections
- ✕History of second cancer (except adequately treated skin cancers or CIS cervix, or disease-free ≥5 years)
- ✕Active autoimmune disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of G3139 (Bcl-2 Antisense) And Rituximab in Patients With Recurrent B-cell Non-Hodgkinâs Lymphomas
In Brief
A Phase 2 clinical trial evaluating oblimersen sodium, rituximab, and 1 other intervention for Cutaneous B-cell Non-Hodgkin Lymphoma and 20 related conditions. Completed, enrolled 48 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCutaneous 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
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2003
First PostedFeb 2003
Primary CompletionJan 2010
TodayJul 2026
First PostedFeb 6, 2003
Enrollment StartJan 1, 2003
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 23.4 years ago
Interventions
oblimersen sodiumbiological
Given IV
rituximabbiological
Given IV
laboratory biomarker analysisother
Correlative studies