Clinical trial · Interventional
Multicentric Study, Three Randomized Arms (R-CVP vs R-CHOP vs R-FM),for Patients With Stage II-IV Follicular Lymphoma
Phase III Multicentric IIL Study, Three Randomized Arms (R-CVP vs R-CHOP vs R-FM),for Treatment of Patients With Stage II-IV Follicular Lymphoma
NCT00774826CI-TRIAL-00004417unknownPhase 3ClinicalTrials.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 purpose of this study is to define an improvement and theassessment of the Time to Treatment Failure in patients randomized in three different arms: R-CVP vs R-CHOP vs R-FM.
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 |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| R-CHOP | Drug | — | UNRESOLVED |
| R-CVP | Drug | — | UNRESOLVED |
| R-FM | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 1
- description
- R-CVP x 3; Restaging if\> RP then R-CVP x 5
- interventionNames
- Drug: R-CVP
- type
- EXPERIMENTAL
- label
- 2
- description
- R-CHOP x 3; Restaging if \> RP then R-CHOP x 3 plus 2 Rituximab
- interventionNames
- Drug: R-CHOP
- type
- EXPERIMENTAL
- label
- 3
- description
- R-FM x 3; Restaging if \> RP then R-FM x 3 plus 2 Rituximab
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histological DIAGNOSIS of B cell follicular lymphoma 2. ECOG performance status 0-2 3. Age range 18-75 4. Ann Arbor Stage: II-IV 5. Assessment of pathology with diagnostics biopsy 6. Presence of one of these criteria: * B Sistemic symptoms B * Extranodale pathology * Cytopenia * Splenomegaly * Leukemia * Serous effusion * Ves \> 20 mm/h * Ldh \> normal value * Nodale or extranodal mass \> 7 cm * 3 or more nodal sites \> 3 cm * Adenopatic syndrome 7. LVEF \> 50% 8. Normal hepatic (bilirubin \< 1.5 mg/dl) and renal functionality (creatinin \< 2 mg/dl). If there is a lymphoma it's allow values of bilirubin \> 1.5 mg/dl and of creatinin \> 2mg/dl 9. No previous treatment for follicolar lymphoma unless RT-IF 10. Lifetime \> 6 mounth 11. Absence of HbsAg, HCV e HIV 12. Negative Coombs Test 13. Negative pregnant test 14. Cotracceptive method during the treatment and the follow three months 15. Formal written consent 16. Ability to follow the patients after the treatment for follow up Exclusion Criteria: 1. Histological Diagnosis of all type of lymphoma unless Follicularlymphoma, CD20 lymphoma, stage IIIb of follicular lymphoma and high degree lymphoma 2. Stage I of Ann Arbor scale 3. Central Nervous system involvement 4. HIV, HBV OR HCV Positivity 5. Cardiac Pathology 6. Positive Coombs Test 7. Previous chemotherapeutic treatment 8. Hypersensitivity to antibodyes or other murine proteins 9. Previous cancer pathology unless in situ cervix and epithelial carcinomas 10. Other type of infections 11. Pregnant and nursing woman
References
Publications (2)
- DERIVEDLuminari S, Ferrari A, Manni M, Dondi A, Chiarenza A, Merli F, Rusconi C, Tarantino V, Tucci A, Vitolo U, Kovalchuk S, Angelucci E, Pulsoni A, Arcaini L, Angrilli F, Gaidano G, Stelitano C, Bertoldero G, Cascavilla N, Salvi F, Ferreri AJM, Vallisa D, Marcheselli L, Federico M. Long-Term Results of the FOLL05 Trial Comparing R-CVP Versus R-CHOP Versus R-FM for the Initial Treatment of Patients With Advanced-Stage Symptomatic Follicular Lymphoma. J Clin Oncol. 2018 Mar 1;36(7):689-696. doi: 10.1200/JCO.2017.74.1652. Epub 2017 Nov 2. PMID 29095677
- DERIVEDRossi D, Bruscaggin A, La Cava P, Galimberti S, Ciabatti E, Luminari S, Rigacci L, Tucci A, Pulsoni A, Bertoldero G, Vallisa D, Rusconi C, Spina M, Arcaini L, Angrilli F, Stelitano C, Merli F, Gaidano G, Federico M, Palumbo GA. The genotype of MLH1 identifies a subgroup of follicular lymphoma patients who do not benefit from doxorubicin: FIL-FOLL study. Haematologica. 2015 Apr;100(4):517-24. doi: 10.3324/haematol.2014.108183. Epub 2015 Jan 16. PMID 25596266