Clinical trial · Interventional
This Study is Being Performed to Evaluate the Effect of Genasense on the Efficacy and the Safety of Rituximab/Fludarabine Combination Treatment in Previously Untreated Subjects With Chronic Lymphocyctic Leukemia(CLL)
A Randomized Phase 3 Study of Fludarabine and Rituximab With or Without Genasense® (Oblimersen Sodium) in Previously Untreated Subjects With Chronic Lymphocytic Leukemia
NCT00517218CI-TRIAL-00001148withdrawnPhase 3ClinicalTrials.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)
To compare the efficacy and safety of combination treatment with Genasense, fludarabine, and rituximab versus combination treatment with fludarabine and rituximab in previously untreated subjects with CLL.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphocytic Leukemia | Lymphoid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Genasense® (, oblimersen sodium G3139) | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Previously untreated subjects with intermediate-or high-risk CLL(modified Rai Stages I-IV) * Measurable disease as primarily established by the National Cancer Institute-sponsored Working Group(NCI-WG) Guidelines for the diagnosis of CLL * Requiring therapy for active disease, as primarily defined by the NCI-WG Guidelines * Eastern Cooperative Oncology Group Performance Status \< 2 * Adequate organ function determined , 14 days prior to the first dose of study medication Exclusion Criteria: * Absolute Lymphocyte count \> 100,000/uL * Prior chemotherapy or other therapy for CLL, including allogeneic transplant * Less than 3 weeks from any prior major surgery at the time of informed consent * Failure to recover from any serious adverse effect of surgery * History of autoimmune hemolytic anemia or autoimmune thrombocytopenia * Active serious infection requiring systemic anti-infective therapy
References
Publications (0)
Data not yet available
No reference posted for this study.