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

Phase 3

• Conditions: Follicular Lymphoma
• Interventions: Drug: R-CVP; Drug: R-CHOP; Drug: R-FM

• Registration Number: NCT00774826
• Lead Sponsor: Fondazione Italiana Linfomi - ETS

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.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2008-10-14
• Study First Submitted QC: 2008-10-16
• Study First Posted: 2008-10-17
• Primary Completion: 2010-09
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-14
• Last Update Posted: 2011-02-15
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 534

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	R-CVP	R-CVP x 3; Restaging if\> RP then R-CVP x 5
2	R-CHOP	R-CHOP x 3; Restaging if \> RP then R-CHOP x 3 plus 2 Rituximab
3	R-FM	R-FM x 3; Restaging if \> RP then R-FM x 3 plus 2 Rituximab

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Assessment of Overall Survival (OS)in patients treated with R-CVP, R-CHOP and R-FM. -	3 years
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 Response Rate(RR) in patients treated with R-CVP, R-CHOP and R-FM.	2 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

Trial Locations

Locations (82)

Ente ecclesiastico Ospedale generale regionale Miulli; 🇮🇹 Acquaviva delle fonti (BA), Italy

Az.Ospedaliera SS.Antonio, Biagio e Cesare Arrigo-U.O.A.Ematologia; 🇮🇹 Alessandria, Italy

Presidio Ospedaliero C.Massaia di Asti; 🇮🇹 Asti, Italy

Istituto Nazionale Tumori; 🇮🇹 Aviano, Italy

IRCCS Istituto tumori Giovanni Paolo II; 🇮🇹 Bari, Italy

Divisione Medicina B Ospedale degli Infermi; 🇮🇹 Biella, Italy

Policlinico Sant'Orsola - Istituto di Ematologia e Oncologia medica L.e A. Seragnoli; 🇮🇹 Bologna, Italy

Ospedale di Bolzano Divisione di Ematologia e Centro Trapianti di Midollo Osseo; 🇮🇹 Bolzano, Italy

A.O.Spedali civili di Brescia; 🇮🇹 Brescia, Italy

Presidio Ospedaliero A.Perrino; 🇮🇹 Brindisi, Italy

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