Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma.

• Status: Active, not recruiting
• Trial end date: 2024-07-15
• Target enrollment: 0
• Participant gender: All

Summary

Follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL) are distinct histologic types of B-cell NHL. Lenalidomide is an immunomodulatory agent with direct and immune-mediated mechanisms of action, as well as clinical activity in NHL. Recent studies in frontline and relapsed/refractory NHL show high activity for lenalidomide plus rituximab (R2), supporting further study of this combination.

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

Details

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

Criteria

Inclusion Criteria:

-- Age ≥18 years

• Histologically confirmed Follicular Lymphoma (Grade 1, 2 or 3a), Marginal Zone Lymphoma, or Mantle Cell Lymphoma

• Must have documented relapsed, refractory or Progressive Disease after last treatment with systemic therapy

• Bi-dimensionally measurable disease

• Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2

• Adequate bone marrow function

• Willingness to follow pregnancy precautions

Exclusion Criteria:

• Histology other than follicular or marginal zone lymphoma or clinical evidence of transformation or Grade 3b follicular lymphoma

• Any medical condition (other than the underlying lymphoma) that requires chronic steroid use

• Subjects taking corticosteroids during the last 1 week prior treatment, unless administered at a dose equivalent to < 20 mg/day of prednisone

• Systemic anti-lymphoma therapy within 28 days or use of antibody agents within 8 weeks use of radioimmunotherapy within 3 months

• Known seropositive for or active viral infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV)

• Known sensitivity or allergy to murine products

• 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.

• 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.