Clinical trial · Interventional
90Y-ibritumomab Tiuxetan Consolidation After 6th R-CHOP Chemotherapy in Patients With Bulky Diffuse Large B Cell Lymphoma
Phase II Study of 90Y-ibritumomab Tiuxetan Treatment as a Consolidation After 6th R-CHOP Chemotherapy in Patients With Limited-stage, Bulky Diffuse Large B Cell Lymphoma
NCT01157988CI-TRIAL-00003649completedPhase 2ClinicalTrials.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 phase II study is aimed at the clinical efficacy and toxicity of 6th R-CHOP chemotherapy followed by ibritumomab tiuxetan (Zevalin) consolidation in patients with limited-stage, bulky diffuse large B cell lymphoma (DLBCL).
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, Large B-Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ibritumomab tiuxetan (Zevalin) | Drug | Ibritumomab Tiuxetan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ibritumomab tuixetan, response, toxicity
- interventionNames
- Drug: ibritumomab tiuxetan (Zevalin)
Primary outcomes (2)
- measure
- Objective response
- timeFrame
- Up to 24 weeks after the infustion of 90Y-ibritumomab tiuxetan
- description
- Patients receive six cycles of R-CHOP chemotherapy per 21-day intervals. Patients with clearly documented progressive disease will be taken off the study when progression is noted. Patients who achieved a complete or partial response after 6th R-CHOP chemotherapy will receive ibritumomab tiuxetan treatment as a consolidation.
- measure
- Safety and toxicity
- timeFrame
- 3 years after the infusion of 90Y-ibritumomab tiuxetan
- description
- After Zevalin treatment, safety profiles will be evaluated with physical examination, vital signs, performance status, serum chemistry and electrolytes, and lymphocytes subset using NCI Common Terminology Criteria for Adverse Events version 3.0, every 4 weeks for 6 months, and then every 3 months for the next 6 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed CD20+ DLBCL * Patients with stage I/II * Bulky disease defined by maximum diameter greater than 10 cm or any mediastinal mass exceeding 1/3 the maximum trans- thoracic diameter (more than 8 cm) * Patients that achieved a complete (CR) or partial response (PR) after 6th R-CHOP chemotherapy * Aged over 18 years * ECOG performance status 0-2. Exclusion Criteria: * Previous history of chemotherapy for diffuse large B cell lymphoma * Prior myeloablative therapy * Prior external-beam radiation to \>25% of active bone marrow * Pregnancy and lactation * \>25% bone marrow infiltration * Platelet counts \<100 000/µl, neutrophil counts \<1500/µl * Children and adolescents under 18 years of age * Presence of CNS involvement with diffuse large B cell lymphoma * Positive HIV serology * Seriously uncontrolled, current infections or other concomitant
References
Publications (1)
- DERIVEDYang DH, Kim WS, Kim SJ, Kim JS, Kwak JY, Chung JS, Oh SY, Suh C, Lee JJ. Pilot trial of yttrium-90 ibritumomab tiuxetan consolidation following rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone chemotherapy in patients with limited-stage, bulky diffuse large B-cell lymphoma. Leuk Lymphoma. 2012 May;53(5):807-11. doi: 10.3109/10428194.2011.635857. Epub 2011 Dec 7. PMID 22035417