Clinical trial · Interventional
Ibritumomab Tiuxetan for Treatment of Non-Follicular CD20+ Indolent Lymphomas
Multicenter Phase II Study for Zevalin® in Patients With Relapsed/Refractory Indolent Lymphomas: Extranodal Marginal Lymphoma of MALT Type, Nodal Marginal Zone B-Cell Lymphoma, and Splenic Marginal B-Cell Lymphoma
NCT00493454CI-TRIAL-00010501terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual.
Summary
Brief summary (as posted)
Primary Objective: * Overall Response Rate (ORR). Secondary Objectives: * The Duration of Response (DR) and Time to Treatment Progression (TTP) in all patients and in the responders. * Complete Responses (CR)/Complete Responses unconfirmed (CRu), and Partial Responses (PR). * Time to next anticancer therapy (TTNT).
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ^111 In Ibritumomab Tiuxetan | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
| Zevalin | Drug | Ibritumomab Tiuxetan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ibritumomab tiuxetan + Rituximab
- description
- Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
- interventionNames
- Drug: Zevalin
- Drug: Rituximab
- Drug: ^111 In Ibritumomab Tiuxetan
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- Evaluation 4 weeks after administration of Zevalin up to 3 years
- description
- Objective response rate (ORR) = number of participants out of all participating with Complete Response (CR) + Partial Response (PR) as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. Response assessed by magnetic resonance imaging (MRI) or computed tomography (CT) scans, every 3 months for the first year and every 6 months up to 3 years following.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. No anti-cancer therapy for three weeks (six weeks if Rituximab, nitrosourea or Mitomycin C) prior to study initiation, and fully recovered from acute toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy. 2. Previously treated patients with a histology of refractory/relapsed indolent lymphomas including: (a) Extranodal marginal lymphoma of MALT type; (b) Nodal Marginal zone B-cell lymphoma (+/- monocytoid cells); (c) Splenic marginal B-cell lymphoma (+/- villous lymphocytes). 3. Signed informed consent 4. Age \>/= 18 years 5. Expected survival \>/= 3 months 6. Pre-study Zubrod performance status of 0, 1, or 2 7. Acceptable hematologic status within two weeks prior to patient registration, including: (a) Absolute neutrophil count (\[segmented neutrophils + bands\] \* total white blood count (WBC)) \>/= 1,500/mm\^3; (b) Platelet counts \>/= 100,000/mm\^3. 8. Female patients who are not pregnant or lactating 9. Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician) 10. Patients previously on Phase II drugs if no long-term toxicity is expected, and the patient has been off the drug for eight or more weeks with no significant post treatment toxicities observed 11. Patients determined to have \< 25% bone marrow involvement with lymphoma within six weeks of registration (define measurement of a bone marrow aspirate or biopsy) (This criteria must be strictly met for adequate patient safety.) 12. Patient should have at least one lesion measuring \>/= 2 cm in a single dimension. Exclusion Criteria: 1. Prior myeloablative therapies with autologous bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue. 2. Platelet count\< 100,000 cells/mm\^3. 3. Presence of hypocellular bone marrow. 4. Patients with history of failed stem cell collection. 5. Prior radioimmunotherapy 6. Presence of Central Nervous System (CNS) lymphoma 7. Patients with HIV. 8. Patients with pleural effusion 9. Patients with abnormal liver function: total bilirubin \> 2.0 mg/dL 10. Patients with abnormal renal function: serum creatinine \> 2.0 mg/dL 11. Patients who have received prior external beam radiation therapy to \> 25% of active bone marrow (involved field or regional) 12. Patients who have received short-acting growth factor support (Leukine, Neupogen, Procrit) within 2 weeks prior to treatment or long-acting growth-factor support (Aranesp), Neulasta) within 4 weeks prior to treatment. 13. Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives 14. Major surgery, other than diagnostic surgery, within four weeks 15. Evidence of transformation in the latest biopsy
References
Publications (0)
Data not yet available
No reference posted for this study.