A two-stage phase III, international, multi-center, randomized, controlled, open-label study to investigate the pharmacokinetics, efficacy and safety of rituximab SC in combination with CHOP or CVP versus rituximab IV in combination with CHOP or CVP in patients with previously untreated follicular lymphoma followed by maintenance treatment with either rituximab SC or rituximab IV. - ND
- Conditions
- Previously untreated, CD20-positive follicular lymphoma (FL) grade 1-2, 3a.MedDRA version: 9.1Level: PTClassification code 10061170
- Registration Number
- EUCTR2010-021377-36-IT
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 410
1. Written informed consent and ability and willingness to comply with the visit schedule and assessments required by the protocol 2. Age = 18 years 3. Histologically confirmed CD20-positive, follicular NHL grade 1, 2 or 3a, according to the WHO classification system. A tumor biopsy (lymph node, bone marrow, etc.) must have been performed within 6 months before study entry with material available for central review 4. No prior treatment. (Note that patients diagnosed in the past who had been on watch and wait” can enter the trial if a tumor biopsy obtained within the last 6 months is available for central review) 5. Patients with at least one of the following signs and symptoms requiring treatment: a) Bulky disease defined as a nodal or extranodal (except spleen) mass = 7 cm in its greatest diameter b) B-symptoms c) Elevated serum LDH or ß2-microglobulin d) Involvement of at least 3 nodal sites (each with a diameter greater than 3 cm) e) Symptomatic spleen enlargement f) Compressive syndrome g) Pleura/peritoneal effusion 6. ECOG performance status of 0-2. 7. Life expectancy of 6 months or more 8. Bi-dimensionally measurable disease (measurable by CT or MRI) 9. A negative serum pregnancy test 1 week prior to treatment must be available both for pre-menopausal women and for women who are less than 2 years after the onset of menopause, or within 14 days with a confirmatory urine pregnancy test within 1 week prior to study treatment start 10. Adequate hematological function within 28 days prior to randomization (unless related to lymphoma infiltration of the bone marrow): a) Hemoglobin (Hb) = 8.0 g/dL (5 mmol/L) b) Absolute neutrophil count (ANC) = 1.5 x 10^9/L c) Platelet count = 100 x 10^9/L.
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
1. Grade 3b follicular lymphoma 2. Transformation to high-grade lymphoma secondary to follicular lymphoma 3. Types of NHL other than follicular lymphoma according to the WHO classification 4. Presence or history of CNS disease (CNS lymphoma or lymphomatous meningitis) 5. Corticoid therapy during the last 4 weeks, unless the dose was below 20 mg/day prednisone equivalent 6. Presence or history of malignancies other than follicular lymphoma. (Patients with a history of curatively treated basal or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix, or any other cancer for which the patient has been in complete remission for at least 5 years are generally eligible) 7. Major surgery within 28 days prior to study entry (lymph node biopsy is not regarded to be a major surgery) 8. Pregnancy or nursing females 9. Fertile men or women of childbearing potential unless they agree to use effective contraception throughout the study and for at least 12 months after the last dose of rituximab 10. Any of the following abnormal laboratory values: a) Serum creatinine >2 mg/dL (197 µmol/L) b) Total bilirubin >1.5 times the upper limit of normal c) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times the upper limit of normal (or >5 times the upper limit of normal in the presence of liver involvement) 11. Active HBV or HCV infection or history of HBV or HCV infection (patients with serological evidence of current or past HBV exposure are excluded unless the serological findings are clearly due to vaccination) 12. Known HIV infection 13. Known active bacterial, viral, fungal or mycobacterial, or any major episode of infections requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening 14. History of organ transplantation including hematological stem cell transplantation 15. Uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of symptomatic bronchospasm) 16. Known hypersensitivity to murine products or any other study drugs or its ingredients 17. Current or recent treatment with another investigational drug or participation in another interventional clinical study within the 30 days prior study entry 18. Any other medical or psychological condition that contraindicates use of an investigational drug, that would preclude adequate collection of study data, or that would compromise the patient’s 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
- Secondary Outcome Measures
Name Time Method