Clinical trial · Interventional
ZAR2007: R-CHOP in Folicular Lymphoma Patients no Treated Previously. Consolidation With 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)
Open Study in Phase II to Evaluate Efficacy of Initial R-CHOP Combination in Folicular Lymphoma no Treated Previously. Consolidation w Ith One Dose of 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)
- 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)
After conventional induction treatment with R-CHOP (Rituximab, cyclophosphamide, adriamycin, vincristine and prednisone) the patients are randomized to: A: Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg B: Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months
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 | Drug | Ibritumomab Tiuxetan | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg
- interventionNames
- Drug: Ibritumomab tiuxetan
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months
- interventionNames
- Drug: Rituximab
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- 2 years
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Folicular Lymphoma CD20-positive, grade 1, 2 or 3a, confirmed in previous 4 months. * Patients no treated previously. * Ann Arbor Stage II, III o IV. * Symptoms or signes wich indicate necesary treatment (GELF criteria): * Ganglionar or extraganglionar mass * B Symptoms * LDH or B2-microglobuline increased * 3 ganglionar territory afected (\> 3 cm) * Esplenomegalia * Compresive syndrome * Pleural/peritoneal effusion * Secondary medular insufiency due to infiltration * Age\> 18 years and \<75 years. * ECOG \< 2 * Adecuate hematological function: Hemoglobin \> 8,0 g/dl (5,0 mmol/L); RAN \>1,5 x 109/L; platelets \> 100 x 109/L * No pregnant women. Women and man should use an appropiate anticonceptive method during the study and one year after * Informed consent Exclusion Criteria: * Transformation in high grade lymphoma * FL grade 3b. * Skin or gastro-intestinal primary lymphoma * History of CNS diseases ( or CNS lymphoma) * Previous treatment * Regulary treatment with corticosteroids (permited \< 20 mg/day prednisone or equivalent). * Previous cancer diseases * Major surgery in 28 days before inclusion in study. * Creatinine \> 2,0 mg/dl (197 mmol/L) * Bilirubin \> 2,0 mg/dl (34 mmol/L), AST (SGOT) \> 3 x upper normal limit. * HIV infection or active infection VHB o VHC \< 4 weeks before inclusion. * Other complicated diseases Criteria investigador: * Life expectancy \< 6 months. * Hipersensibility to Ibritumomab tiuxetan, rituximab, other murines proteins or any excipients. * Treatment in other experimental study in previous 30 days * Any medical o psicologycal condition that can modify the capacity to give the consent
References
Publications (1)
- DERIVEDLopez-Guillermo A, Canales MA, Dlouhy I, Mercadal S, Briones J, Martin Garcia-Sancho A, Sancho JM, Moraleda JM, Terol MJ, Salar A, Palomera L, Gardella S, Jarque I, Ferrer S, Bargay J, Lopez A, Panizo C, Muntanola A, Montalban C, Conde E, Hernandez MT, Soler A, Garcia Marco JA, Deben G, Marin J, Tomas JF; PETHEMA/GELTAMO/GELCAB Spanish Intergroup. A randomized phase II study comparing consolidation with a single dose of 90Y ibritumomab tiuxetan vs. maintenance with rituximab for two years in patients with newly diagnosed follicular lymphoma responding to R-CHOP. Long-term follow-up results. Leuk Lymphoma. 2022 Jan;63(1):93-100. doi: 10.1080/10428194.2021.1971216. Epub 2021 Aug 30. PMID 34459702