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

Fondazione Italiana Linfomi - ETS

Status and phase: Unknown; Phase 3

Conditions: Follicular Lymphoma

Treatments: Drug: R-FM; Drug: R-CVP; Drug: R-CHOP

Study type: Interventional

Funder types: Other

Identifiers

NCT00774826

IIL-FOLL05

Eudract Number 2005-005406-24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 534 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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534 participants in 3 patient groups

1

Experimental group

Description:

R-CVP x 3; Restaging if\> RP then R-CVP x 5

Treatment:

Drug: R-CVP

2

Experimental group

Description:

R-CHOP x 3; Restaging if \> RP then R-CHOP x 3 plus 2 Rituximab

Treatment:

Drug: R-CHOP

3

Experimental group

Description:

R-FM x 3; Restaging if \> RP then R-FM x 3 plus 2 Rituximab

Treatment:

Drug: R-FM