Rituximab With or Without Lenalidomide in Treating Patients With Previously Untreated Follicular Lymphoma
- Registration Number
- NCT01307605
- Lead Sponsor
- Swiss Group for Clinical Cancer Research
- Brief Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Lenalidomide may stop the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer. It is not yet known whether rituximab is more effective when given alone or together with lenalidomide in treating patients with follicular lymphoma.
PURPOSE: This randomized phase II trial is studying rituximab to see how well it works compared with giving rituximab together with lenalidomide in treating patients with previously untreated follicular lymphoma.
- Detailed Description
OBJECTIVES:
Primary
* To determine the activity of rituximab in combination with lenalidomide versus rituximab alone in patients with previously untreated follicular lymphoma in need of therapy.
Secondary
* To determine the safety of these regimens in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to grade of disease (grades 1 or 2 vs 3a), presence of bulky disease (defined as masses ≥ 6 cm) (yes vs no), Follicular Lymphoma International Prognostic Index score (1 or 2 vs ≥ 3), and participating centers. Patients are randomized to 1 of 2 treatment arms.
* Arm A: Patients receive rituximab IV on day 1 in weeks 1, 2, 3, 4 and weeks 12, 13, 14, 15 in the absence of disease progression or unacceptable toxicity.
* Arm B: Patients receive rituximab IV as in arm A. Patients also receive oral lenalidomide once daily, starting 14 days before first rituximab administration and last until 14 days after the last rituximab administration, in the absence of disease progression or unacceptable toxicity.
All patients undergo restaging at week 10. Patients who show less than a minimal response (i.e., reduction of more than 25% in sum of product of diameters \[SPD\]) are off study treatment and transferred to the follow-up phase. Patients undergo a second restaging in week 23.
Some patients may undergo biopsies and blood and bone marrow sample collection periodically for biomarker studies.
After completion of study treatment, patients are followed up periodically for 20 years.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 154
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rituximab Rituximab Rituximab (MabThera®) will be administered for a maximum of 8 infusions at weeks 1, 2, 3, 4 and again at weeks 12, 13, 14, 15 if the first restaging at week 10 (+/- 1 week) shows a partial response with at least more than 25% reduction in sum of product of diameters Rituximab plus Lenalidomide lenalidomide Lenalidomide will be administered as 15 mg flat dose daily, starting 14 days before first and stopping 14 days after last rituximab administration.
- Primary Outcome Measures
Name Time Method Complete response (CR) at week 23 The evaluation of CR is outlined in Appendix 1 Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma.
- Secondary Outcome Measures
Name Time Method Best Overall response (OR) within 12 weeks OR is defined as either:
* the disappearance of all evidence of disease (CR or CRu)
* the regression of measurable disease with no new sites (PR)Progression-free survival until disease progression, for up to 10 years after randomization PFS will be calculated from randomization until the first event of interest:
* disease progression or relapse according to criteria of Cheson et a.l 1999
* death from any causeTime to first off-trial anti-lymphoma therapy until off-trial therapy administration, for up to 10 years after randomization This will be calculated from randomization until the start of the first off-trial anti-lymphoma treatment.
Patients not receiving any off-trial anti-lymphoma treatment will be censored at the last follow-up visit.Overall survival every 6 months for up to 10 years after randomization OS will be calculated from randomization until death. Patients not experiencing an event will be censored at the last date they were known to be alive.
Best overall response (OR) within 24 weeks OR is defined as either:
* the disappearance of all evidence of disease (CR or CRu)
* the regression of measurable disease with no new sites (PR)Adverse events, including laboratory abnormality assessments and vital signs from inclusion until 30 days after treatment discontinuation This will be evaluated using the NCI CTCAE v4.0
Trial Locations
- Locations (33)
University Hospital of Linkoping
🇸🇪Linkoping, Sweden
Karolinska University Hospital - Huddinge
🇸🇪Stockholm, Sweden
Sunderbyn Hospital
🇸🇪Lulea, Sweden
Sahlgrenska University Hospital
🇸🇪Göteborg, Sweden
City Hospital Triemli
🇨🇭Zurich, Switzerland
Karolinska University Hospital - Solna
🇸🇪Stockholm, Sweden
Sundsvall Hospital
🇸🇪Sundsvall, Sweden
Uppsala University Hospital
🇸🇪Uppsala, Sweden
Haukeland Hospital - University of Bergen
🇳🇴Bergen, Norway
Kantonsspital Bruderholz
🇨🇭Bruderholz, Switzerland
University Hospital
🇨🇭Geneva, Switzerland
Kantonsspital Liestal
🇨🇭Liestal, Switzerland
Sorlandet Sykehus HF Kristiansand
🇳🇴Kristiansand, Norway
Ullevaal University Hospital
🇳🇴Oslo, Norway
Universitaetsspital-Basel
🇨🇭Basel, Switzerland
Inselspital Bern
🇨🇭Bern, Switzerland
Kantonsspital - St. Gallen
🇨🇭St. Gallen, Switzerland
Helse Stavanger HF
🇳🇴Stavanger, Norway
Kantonsspital Aarau
🇨🇭Aarau, Switzerland
Saint Claraspital AG
🇨🇭Basel, Switzerland
Kantonsspital Graubuenden
🇨🇭Chur, Switzerland
Regionalspital
🇨🇭Thun, Switzerland
Klinik Hirslanden
🇨🇭Zurich, Switzerland
Kantonsspital Baden
🇨🇭Baden, Switzerland
Spitalzentrum Oberwallis - Brig
🇨🇭Brig, Switzerland
Kantonsspital Winterthur
🇨🇭Winterthur, Switzerland
University Hospital of North Norway - Tromso
🇳🇴Tromso, Norway
St. Olavs University Hospital
🇳🇴Trondheim, Norway
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
🇨🇭Bellinzona, Switzerland
Kantonsspital Olten
🇨🇭Olten, Switzerland
UniversitaetsSpital Zuerich
🇨🇭Zurich, Switzerland
Lund University Hospital
🇸🇪Lund, Sweden
Norrlands University Hospital
🇸🇪Umea, Sweden