Multicenter, open, phase III, randomized study in patients with advanced follicular lymphoma to evaluate the benefits of maintenance therapy with Rituximab (MabThera®) after induction of the response with chemotherapy plus Rituximab, compared to a treatment without maintenance therapy
- Conditions
- C82-C82 Follicular lymphomaFollicular lymphoma
- Registration Number
- PER-039-05
- Lead Sponsor
- PRODUCTOS ROCHE Q.F.S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 10
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Clinical evaluation<br>Measure:Event-free survival: Time from randomization to progression, relapse, death from any cause or institution of a new anti-lymphoma treatment<br>Timepoints:Induction period: Days 1 to 8.<br>Maintenance / Observation phase: Every 8 weeks and a final evaluation at 2 years.<br>Follow-up Phase: Every 3 months the first year and every 6 months for 2 more years<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Clinical evaluation<br>Hematological laboratory analysis.<br>Laboratory analysis of biochemistry.<br>LDH and B2 microglobulin.<br>Computed tomography.<br>Measures of tumor lesions.<br>Bone marrow biopsy<br>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.<br>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<br>