Clinical trial · Interventional
Efficacy and Safety of Nipent, Cytoxan and Rituxan in the Treatment of Chronic Lymphocytic Leukemia.
A Multicenter, Open-Label Study of Nipent, Cytoxan and Rituxan in Patients With Previously Untreated or Treated Chronic Lymphocytic Leukemia.
NCT00131313CI-TRIAL-00000104unknownPhase 4ClinicalTrials.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)
This research study measures the safety and efficacy of the combination of three drugs that are approved, Nipent, Rituxan and Cytoxan in the treatment of Chronic Lymphocytic Leukemia (CLL). These drugs are being given together for investigational purposes as the specific combination of these three drugs has not been approved for treatment of CLL by the FDA.
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 |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nipent, Cytoxan, Rituxan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Efficacy response rate
Secondary outcomes (4)
- measure
- Time to progression
- measure
- Time to treatment failure
- measure
- Toxicity
- measure
- Incidence and severity of adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Stage II, III or IV Chronic Lymphocytic Leukemia * Disease requires chemotherapeutic treatment * CT or MRI scan confirming measurable tumor size * Documentation of CD markers * Up to one prior treatment regimen * Expected survival greater than 6 months * ECOG performance status of 0-2 * Adequate renal, bone marrow and liver functions * Negative pregnancy test (females of childbearing potential) * Must agree to use acceptable birth control, if fertile * Must complete Informed Consent * No heart disease and must have adequate cardiac function * Must test negative for viral Hepatitis B and C Exclusion Criteria: * More than one prior treatment for Chronic Lymphocytic Leukemia * Known sensitivity to Nipent, Rituxan or Cytoxan or any component of these drugs * Known HIV or AIDS illness * Thyroid disease requiring medication * History of any malignancy that could affect the diagnosis or assessment of the study treatment * Pregnancy or breast feeding * Evidence of Hepatitis B or C infection * Inability to comply with the requirements of the study
References
Publications (0)
Data not yet available
No reference posted for this study.