Multicentric Study, Three Randomized Arms (R-CVP vs R-CHOP vs R-FM),for Patients With Stage II-IV Follicular Lymphoma

Conditions

Follicular Lymphoma

Keywords

Follicular lymphoma, Rituximab

Brief summary

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.

Detailed description

Assessment of Overall Survival (OS)in patients treated with R-CVP, R-CHOP and R-FM. -Assessment of Progression Free Survival (PFS)in patients treated with R-CVP, R-CHOP - Assessment of Duration of Response (DR)in patients treated with R-CVP, R-CHOP and R-FM. - Assessment of Response Rate(RR) in patients treated with R-CVP, R-CHOP and R-FM. - Assessment of molecular Response Rate in patients treated with R-CVP, R-CHOP and R-FM. - Assessment of toxicity of R-CVP, R-CHOP, R-FM treatments.

Stefano Luminari, Luigi Marcheselli, Martina Manni, A. Anastasia, Umberto Vitolo et al. (21 authors)

Hematological Oncology2017-06-014 citations

10.1002/hon.2438_91

The genotype of MLH1 identifies a subgroup of follicular lymphoma patients who do not benefit from doxorubicin: FIL-FOLL study

Davide Rossi, Alessio Bruscaggin, P. La Cava, Sara Galimberti, Elena Ciabatti et al. (20 authors)

Haematologica2015-01-167 citations

10.3324/haematol.2014.108183

Minimal Residual Disease after Conventional Treatment Significantly Impacts on Progression-Free Survival of Patients with Follicular Lymphoma: The FIL FOLL05 Trial

Sara Galimberti, Stefano Luminari, Elena Ciabatti, Susanna Grassi, Francesca Guerrini et al. (29 authors)

Clinical Cancer Research2014-10-14113 citations

10.1158/1078-0432.ccr-14-0407

Updated results of the FOLL05 phase III trial from the Fondazione Italiana Linfomi comparing R-CVP, R-CHOP, and R-FM in patients with advanced follicular lymphoma.

Stefano Luminari, Alessandra Dondi, Luigi Marcheselli, Giuseppe Rossi, Carola Boccomini et al. (16 authors)

Journal of Clinical Oncology2014-05-201 citations

10.1200/jco.2014.32.15_suppl.8530

The prognostic role of post-induction FDG-PET in patients with follicular lymphoma: a subset analysis from the FOLL05 trial of the Fondazione Italiana Linfomi (FIL).

Luminari S, Biasoli I, Versari A, Rattotti S, Bottelli C, Rusconi C, Merli F, Spina M, Ferreri AJ, Zinzani PL, Gallamini A, Franceschetto A, Boccomini C, Franceschetti S, Salvi F, Raimondo FD, Carella AM, Micol Q, Balzarotti M, Musto P, Federico M, Federico M.

2014-01-1058 citations

10.1093/annonc/mdt562

Interventions

DRUGR-CVP

Rituximab: 375 mg/mq day 1 Ciclofosfamide: 750 mg/mq day 1, Vincristina: 1,4 mg/mq day 1 Prednisone: 40 mg/mq day 1-5,

DRUGR-CHOP

Rituximab: 375 mg/mq day 1 Ciclofosfamide: 750 mg/mq day 1 Doxorubicina: 50 mg/mq day 1 Vincristina: 1.4 mg/mq day 1 Prednisone: 100 mg/mq day 1-5

DRUGR-FM

Rituximab: 375 mg/mq day 1, Fludarabina: 25 mg/mq day 1-3, Mitoxantrone: 10 mg/mq day 1,

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Assessment of the Time to Treatment Failure (TTF)in patients treated with R-CVP, R-CHOP and R-FM.	2 years

Secondary

Measure	Time frame
Assessment of Progression Free Survival (PFS)in patients treated with R-CVP, R-CHOP	2 years
Assessment of Duration of Response (DR)in patients treated with R-CVP, R-CHOP and R-FM.	2 years
Assessment of Overall Survival (OS)in patients treated with R-CVP, R-CHOP and R-FM. -	3 years
Assessment of molecular Response Rate in patients treated with R-CVP, R-CHOP and R-FM.	2 years
Assessment of toxicity of R-CVP, R-CHOP, R-FM treatments.	2 years
Assessment of Response Rate(RR) in patients treated with R-CVP, R-CHOP and R-FM.	2 years

Countries

Italy

Outcome results

None listed