None listed
Conditions
Interventions
Group 1 Type of group
Induction phase: variable duration (until the patient achieves remission). Multiple schedules will be carried out all with Rituximab included: CVP (Cyclophosphamide, vincristine, prednisone), FCM (Fludarabine, cyclophosphamide, mitoxantrone), MCP (Mitoxantrone, chlorambucil, prednisone), CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone)
Maintenance Phase: Duration 24 months. Rituximab 375 mg / m2 administered as an intravenous infusion every 8 weeks. Infusion rate 50 mg / h can be
Induction phase: variable duration (until the patient achieves remission). Multiple schedules will be carried out all with Rituximab included: CVP (Cyclophosphamide, vincristine, prednisone), FCM (Fludarabine, cyclophosphamide, mitoxantrone), MCP (Mitoxantrone, chlorambucil, prednisone), CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone)
Observation Phase: Duration 24 months. Maintenance treatment will not be given, only observation for the aforementioned period of time.
Sponsors
PRODUCTOS ROCHE Q.F.S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1) Follicular lymphoma grade 1, 2 or 3 confirmed by histology with a lymph node biopsy performed within 4 months before admission to the study. 2) Detectable tumor mass on admission to the study, according to the GELF criteria. 3) Adequate haematological function within 28 days prior to enrollment. 4) Women who are not breastfeeding, who use effective methods of contraception, who are not pregnant and who agree not to become pregnant during participation in the study and during the following 12 months. Men who agree not to have children during participation in the study and during the following 12 months. 5) Have previously signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1) Transformation to high grade lymphoma. 2) Follicular lymphoma grade 3b. 3) Presence or history of illness in CNS. 4) Patients treated regularly with corticosteroids during the last 4 weeks. 5) Patients with previous or concomitant malignancies. 6) Major surgery within 28 days prior to enrollment. 7) Impaired renal function: serum creatinine> 2.0 mg / dl (197 pmoI / L) 8) Altered liver function: Total bilirubin> 2.0 mg / dL (34 pmol / L), AST (SGOT)> 3 times the upper normal limit, except that these abnormalities are related to the lymphoma. 9) Infection known to HIV or active HBV or HCV infection less than or equal to 4 weeks on admission. 10) Serious underlying medical disorders, which may alter the patient´s ability to participate in the study. 11) Life expectancy <6 months. 12) Known sensitivity or allergy to murine products. 13) Treatment within the framework of a clinical study within 30 days before entering the study. 14) Any other co-existing medical or psychological disorder that impedes participation in the study or compromises the ability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation Measure:Event-free survival: Time from randomization to progression, relapse, death from any cause or institution of a new anti-lymphoma treatment Timepoints:Induction period: Days 1 to 8. Maintenance / Observation phase: Every 8 weeks and a final evaluation at 2 years. Follow-up Phase: Every 3 months the first year and every 6 months for 2 more years | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation Hematological laboratory analysis. Laboratory analysis of biochemistry. LDH and B2 microglobulin. Computed tomography. Measures of tumor lesions. Bone marrow biopsy Measure:1) Free survival of events from the moment of entering the study called SLE-2. 2) Time to progression (TP). 3) Time until the next anti-lymphoma treatment (TSTL). 4) Time until the next chemotherapeutic treatment (TSTQ). 5) Overall response rate. 6) Duration of the response (DR). 7) Disease Free Survival (SLE). 8) Overall survival 9) Rate of transformation in the first progression. Timepoints:Days 1 to 8 of the induction. Every 8 weeks and a final evaluation after 2 years of maintenance. Every 3 months of the first year and every 6 months for 2 more years of follow-up | — |
Countries
Belgium, Czech Republic, Denmark, Finland, Portugal, Spain, United Kindgdom
Contacts
Public ContactPilar Leslie Kikushima
PRODUCTOS ROCHE Q.F.S.A.
Outcome results
None listed