Clinical Trials Detalhe
Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma)
General Information
Gender
ALL
Age
N/A
Phase
PHASE3
Study Type
INTERVENTIONAL
Location
Instituto Portugues de Oncologia de Lisboa, Francisco Gentil (Lisbon, Portugal)
Local Institution - 330 (Lisbon, Portugal)
Instituto Portugues de Oncologia do Porto, Francisco Gentil (Porto, Portugal)
Local Institution - 331 (Porto, Portugal)
Clinicaltrial.gov
https://classic.clinicaltrials.gov/ct2/show/NCT01938001Summary
This double-blind randomized, parallel group study will evaluate the efficacy and safety of lenalidomide (Revlimid, CC-5013) in combination with rituximab (MabThera/Rituxan) in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma. Patients will be randomized to receive either lenalidomide or placebo for twelve 28-day cycles in combination with rituximab. Anticipated time on study treatment is 1 year.
Conditions
Lymphoma, Non-Hodgkin
Eligibility
Inclusion Criteria: * Age ≥18 years at the time of signing the informed consent document. * Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted. * Histologically confirmed marginal zone lymphoma or follicular lymphoma (grade 1, 2 or 3a; CD20+ by flow cytometry or histochemistry). * Previously treated with at least one prior systemic chemotherapy, immunotherapy or chemoimmunotherapy and have received at least 2 previous doses of rituximab. * Documented relapsed, refractory or progressive disease after treatment with systemic therapy and must not be rituximab-refractory. * Investigator considers rituximab monotherapy appropriate. * Bi-dimensionally measurable disease on cross sectional imaging by X-ray computed tomography (CT) or magnetic resonance imaging (MRI). * Need of treatment for relapsed, progressed or refractory disease as assessed by the investigator. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. * Adequate bone marrow function. * Willingness to follow study visit schedule, pregnancy precautions and other protocol requirements. Exclusion Criteria: * Histology other than follicular or marginal zone lymphoma or clinical evidence of transformation or Grade 3b follicular lymphoma. * Subjects taking corticosteroids during the last week prior to study treatment, unless administered at a dose equivalent to \< 20 mg/day prednisone or prednisolone. * Systemic anti-lymphoma therapy within 28 days or use of antibody agents within 8 weeks use of radioimmunotherapy within 6 months. * Known seropositive for or active viral infection with hepatitis B virus (HBV) or/and human immunodeficiency virus (HIV). * Known hepatitis C virus (HCV) positive with chronic HCV or active viral infection with HCV hepatitis requiring anti-viral medication (at time of randomization). * Life expectancy \< 6 months. * Known sensitivity or allergy to murine products. * Prior history of malignancies, other than follicular or marginal zone lymphoma, unless the subject has been free of the disease for ≥ 5 years. * Prior use of lenalidomide. * Known allergy to thalidomide. * Neuropathy \> Grade 1. * Presence or history of central nervous system involvement by lymphoma. * Subjects who are at a risk for a thromboembolic event and are not willing to take prophylaxis for it. * Uncontrolled intercurrent illness. * Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document. * Pregnant or lactating females. * Any condition that places the subject at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study.