A multicentre, phase III, open-label, randomized study in patients with advanced follicular lymphoma evaluating the benefit of maintenance therapy with rituximab (Mabthéra® ) after induction of response with chemotherapy plus rituximab in comparison with no maintenance therapy. - PRIMA
- Conditions
- Follicular lymphoma
- Registration Number
- EUCTR2004-001756-36-FI
- Lead Sponsor
- GELA (Groupe d'Etude du Lymphome de l'Adulte)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 640
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 < 2 on the ECOG scale (see appendix E1).
- Adequate hematological function (unless those abnormalities are related to lymphoma extension) within 28 days prior to registration, including:
• Hemoglobin = 8.0 g/dL (5.0 mmol/L)
• Absolute neutrophil count (ANC) = 1.5 109/L
• Platelet count = 100 109/L
- Women are not breast feeding, are using effective contraception, are not pregnant and agree not to become pregnant during participation in the trial and during the 12 months thereafter. Men agree not to father a child during participation in the trial and during the 12 months thereafter.
- Having previously signed a written informed consent form.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- 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 < 20 mg/day prednisone.
- Patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer.
- Major surgery (excluding lymph node biopsy) within 28 days prior to registration.
- Poor renal function: Serum creatinine > 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.
- 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). Judgment is up to the investigator.
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate in patients with advanced follicular lymphoma the benefit of maintenance therapy with rituximab after induction of response with chemotherapy plus rituximab in comparison with no maintenance therapy ;Secondary Objective: To evaluate response rates, event driven survival endpoints (Event Free Survival, Progression Free Survival, Overall Survival) and quality of life of four different chemotherapy regimens combined with rituximab, with or without maintenance with rituximab, for first line treatment of advanced stage follicular lymphoma.;Primary end point(s): Event Free Survival (EFS) defined as the time from randomization to progression, relapse, death from any cause, or requirement of a new treatment whatever the reason.
- Secondary Outcome Measures
Name Time Method