Follicular lymphoma MedDRA version: 16.1 Level: LLT Classification code 10029473 Term: Nodular (follicular) lymphoma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Mabthera
Product Name: MABTHERA
Product Code: R
Pharmaceutical Form:
Sponsors
LYSA (The Lymphoma Study Association)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically confirmed follicular lymphoma grade 1, 2 or 3a (biopsy = 4 months). - Patients previously untreated. - Bulky disease at study entry according to the GELF criteria: - Age must be > 18 years. - Performance status =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Transformation to high-grade lymphoma (secondary to “low-grade” follicular lymphoma). - Grade 3b follicular lymphoma. - Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis). - Patients regularly taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to 2.0 mg/dL (197 µmol/L), - Poor hepatic function: total bilirubin > 2.0 mg/dL (34 µmol/L), AST (SGT) > 3 x the upper limit of normal unless these abnormalities are related to lymphoma. - Known HIV infection or active HBV or HCV infection = 4 weeks at registration. Patients with any serological evidence of current or past hepatitis B exposure are excluded unless the serological findings are clearly due to vaccination. - Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease). - Life expectancy < 6 months - Known sensitivity or allergy to murine products - Treatment within a clinical trial within 30 days prior to trial entry - Any other co-existing medical or psychological condition that will preclude participation in the study or compromise ability to give informed consent. - Adult patient under tutelage (not competent to sign informed consent form).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the benefit of maintenance therapy with rituximab as measured by progression-free survival (PFS) in comparison with no maintenance therapy after induction of response with chemotherapy plus rituximab in patients with high tumor burden follicular lymphoma;Secondary Objective: To evaluate event-free survival (EFS), overall survival (OS), time to next anti-lymphoma treatment (TTNLT), time to next chemotherapy treatment (TTNCT), response rates at the end of maintenance treatment, transformation rate at first relapse and quality of life for three different chemotherapy regimens combined with rituximab, with or without maintenance rituximab, for first line treatment of high tumor burden, follicular lymphoma. To assess safety of rituximab maintenance therapy over 2 years as measured by the incidence of toxicity.;Primary end point(s): The primary efficacy parameter is progression-free survival (PFS). PFS will be measured from the day of randomization to the date of first documented disease progression, relapse or death from any cause. Responding patients and patients who are lost to follow up will be censored at their last tumor assessment date. Progression-free survival will be assessed for each study patient by the investigator. In addition, an independent, blinded radiology/oncology review will be performed by an external contractor. The investigator assessment of response and progression will be considered as the definitive analysis and the results of the analysis based on the independent blinded review will be considered as confirmatory. | — |
Countries
Belgium, Czech Republic, Denmark, Finland, Portugal, Spain, United Kingdom
Outcome results
None listed