Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma)

• Status: Active, not recruiting
• Trial end date: 2022-01-26
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: Lenalidomide; Rituximab; Thalidomide

Criteria

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.