Clinical trial · Interventional
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma
Phase II Study of Ibritumomab Tiuxetan (Zevalin®) in Patients With Previously Untreated Marginal Zone Lymphoma
NCT00453102CI-TRIAL-00020404completedPhase 2Results postedClinicalTrials.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)
Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).
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 |
|---|---|---|---|
| Marginal Zone Lymphoma | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ibritumomab Tiuxetan | Drug | Ibritumomab Tiuxetan | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zevalin + Rituximab
- description
- Ibritumomab Tiuxetan (Zevalin) + Rituximab
- interventionNames
- Drug: Rituximab
- Drug: Ibritumomab Tiuxetan
Primary outcomes (1)
- measure
- Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy.
- timeFrame
- 12 weeks post-therapy
- description
- The overall response rate (ORR) including complete response (CR), complete response unconfirmed (CRu), and partial response (PR) in participants receiving protocol therapy.
Secondary outcomes (5)
- measure
- Rate of Progression-Free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 18 years old with previously untreated, histologically confirmed Marginal Zone Lymphoma (non-gastric extranodal MZL, splenic MZL and nodal MZL) or gastric MZL that did not respond to antibiotic therapy given up to 6 months prior to enrollment, but not less than 2 months) * Measurable and evaluable disease * All stages are eligible * Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (Appendix B) * Willing and able to provide written informed consent * Women of childbearing potential must have a negative pregnancy test at study entry and must agree to use effective contraception while on treatment and for 6 months after treatment * Life expectancy of at least 6 months Exclusion Criteria: * Prior chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids, or systemic biologic anticancer therapy before beginning study treatment. * ≥ 25% lymphoma bone marrow involvement * Platelet count \< 100,000 cells/mm³ * Neutrophil count \< 1,500 cells/mm³ * Known history of HIV infection * Pregnant or lactating (pregnancy test is required for all female patients of childbearing potential) * Woman of childbearing potential or sexually active man unwilling to use adequate contraceptive protection. * Physical or mental condition that makes patient unable to complete specified follow-up assessments
References
Publications (1)
- BACKGROUNDLossos IS, Fabregas JC, Koru-Sengul T, Miao F, Goodman D, Serafini AN, Hosein PJ, Stefanovic A, Rosenblatt JD, Hoffman JE. Phase II study of (90)Y Ibritumomab tiuxetan (Zevalin) in patients with previously untreated marginal zone lymphoma. Leuk Lymphoma. 2015 Jun;56(6):1750-5. doi: 10.3109/10428194.2014.975801. Epub 2014 Nov 20. PMID 25315074