Clinical trial · Interventional
Zevalin® Followed by Rituxan® Maintenance in Previously Treated Low Grade Non-Hodgkin's Lymphoma
Zevalin® (Ibritumomab Tiuxetan) Followed by Rituxan® (Rituximab) Maintenance in Previously Treated Low Grade Non-Hodgkin's Lymphoma
NCT00168727CI-TRIAL-00069028completedPhase 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)
The purpose of this study is to determine the safety and effectiveness of a treatment regimen using Zevalin® plus Rituxan® for patients who have low grade Non-Hodgkin's Lymphoma (NHL) or relapsed Non-Hodgkin's lymphoma and have been previously treated. This study will use an experimental scheduling regimen. No chemotherapy will be used in this study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Low-Grade | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ibritumomab tiuxetan (Zevalin®) | Drug | Ibritumomab Tiuxetan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determine overall response rate, event-free survival, time-to-progression, time-to-next-therapy, and freedom-from-relapse in pts with low-grade lymphoma in first or second relapse treated with Zevalin® followed by 2 yrs of Rituxan maintenance therapy
Secondary outcomes (1)
- measure
- Evaluate relative response rates in populations with and without prior rituximab therapy, in first versus second relapse, and with and without bulky (> 5 cm in greatest diameter) disease.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Follicular non-Hodgkin's lymphoma including SLL in first or second relapse. * No anticancer therapy for three wks (six wks if nitrosourea or Mitomycin C); not rituximab refractory. * Age \>= 18 years, not pregnant or lactating. * Expected survival \>= 3 mths; PS 0, 1, or 2. * ANC \>= 1,500/mm3, platelet counts \>= 100,000/mm3. * Total bilirubin \> 2.0 mg/dL, creatinine \> 2.0 mg/dL. * Total lymphocyte count \< 5,000/mm3 for SLL. * \<25% bone marrow involvement with lymphoma. Exclusion Criteria: * Prior ABMT or ASCT, hypocellular or marked reduction in bone marrow precursors, or history of failed stem cell collection. * Bulky areas of disease more than 10 cm in diameter. * Patients with CLL, CNS, or mantle cell lymphoma. * Hx of HIV/AIDS related lymphoma, hepatitis B or C. * Prior radioimmunotherapy or XRT to \>25% of active bone marrow. * G-CSF or GM-CSF within 2 wks, pegylated G-CSF within 4 wks of treatment
References
Publications (0)
Data not yet available
No reference posted for this study.