Clinical trial · Interventional
Zevalin (Ibritumomab Tiuxetan) for Early Stage Indolent Lymphomas
Phase II Study of Zevalin for the Treatment of Early-Stage Indolent Lymphomas
NCT00493467CI-TRIAL-00060860completedPhase 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)
The goal of this clinical research study is to find out if giving (Rituxan) rituximab with 90Y (ibritumomab tiuxetan) (90 Y Zevalin®) may be effective in treating low-grade lymphoma. The safety of this combination treatment will also be studied.
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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ibritumomab Tiuxetan (Zevalin) | Drug | Ibritumomab Tiuxetan | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zevalin
- description
- Ibritumomab Tiuxetan (Zevalin) + Rituximab
- interventionNames
- Drug: Ibritumomab Tiuxetan (Zevalin)
- Drug: Rituximab
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- Up to 5 years; Evaluation at 3-month intervals during Year 1, then every 6 months to Year 4. The median follow-up was 56 months for censored observations.
- description
- ORR defined as the percentage of number of complete response (CR), complete response unconfirmed (CRu) or partial response (PR) in patients treated using International Working Group (IWG) revised response criteria for Malignant Lymphoma. ORR to therapy is evaluated after three months using radiographic and clinical parameters to assess response. CR: Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms. CRu: A residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameters (SPD). Individual nodes that were previously confluent must have regressed by more than 75% in their SPD compared to the original mass and indeterminate bone marrow. PR: ≥ 50% decrease in SPD of the six largest dominant nodes or nodal masses. No increase in the size of other nodes, liver or spleen and no new sites of disease.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. New diagnosis of low-grade indolent lymphomas Stage I-II. Patients with multiple skin lesions will be eligible provided that the skin is the only site of involvement. 2. Histology includes Indolent cluster of differentiation antigen 20 (CD20)+ lymphomas including: Follicular lymphoma, Extranodal marginal lymphoma of MALT type, Nodal Marginal zone B-cell lymphoma (+/- monocytoid cells), and Splenic marginal B-cell lymphoma (+/- villous lymphocytes). 3. Signed Informed Consent. 4. Age \>/= 18 years. 5. Pre-study Zubrod performance status of 0, 1, or 2. 6. Acceptable hematologic status within two weeks prior to patient registration, including: absolute neutrophil count (\[segmented neutrophils + bands\] x total WBC) \>/= 1, 500/mm\^3, total lymphocyte count \</= 5,000/mm\^3 and platelet counts \>/= 100,000/mm\^3. 7. Female patients who are not pregnant or lactating. 8. Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician, however abstinence is not an acceptable method). 9. Patients determined to have \< 25% bone marrow involvement with lymphoma within six weeks of registration (define measurement of a bone marrow aspirate or biopsy). 10. Patient should have at least one lesion measuring \>/= 1.5 cm in a single dimension. Measurable cutaneous lesions are allowed. Exclusion Criteria: 1. Presence of central nervous system (CNS) lymphoma. 2. Patients with HIV or AIDS-related lymphoma. 3. Patients with pleural effusion. 4. Patients with abnormal liver function: total bilirubin \> 2.0 mg/dL. 5. Patients with abnormal renal function: serum creatinine \> 2.0 mg/dL. 6. Patients who have received prior external beam radiation therapy to \> 25% of active bone marrow (involved field or regional). 7. Impaired bone marrow reserve as indicated by \< 15% bone marrow cellularity 8. Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives. 9. Major surgery, other than diagnostic surgery, within four weeks. 10. Evidence of transformation in the latest biopsy.
References
Publications (0)
Data not yet available
No reference posted for this study.