Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma.
- Conditions
- Lymphoma, Non-Hodgkin
- Registration Number
- NCT01996865
- Lead Sponsor
- Celgene
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 503
Inclusion Criteria:<br><br>-- Age =18 years<br><br> - Histologically confirmed Follicular Lymphoma (FL, Grade 1, 2, 3a, or 3b),<br> Transformed FL, Marginal Zone Lymphoma, or Mantle Cell Lymphoma<br><br> - Must have documented relapsed, refractory or Progressive Disease after last<br> treatment with systemic therapy<br><br> - Bi-dimensionally measurable disease<br><br> - Eastern Cooperative Oncology Group (ECOG) Performance status < 2<br><br> - Adequate bone marrow function<br><br> - Willingness to follow pregnancy precautions<br><br>Exclusion Criteria:<br><br> - Histology other than follicular or marginal zone lymphoma or clinical evidence of<br> transformation or Grade 3b follicular lymphoma<br><br> - Any medical condition (other than the underlying lymphoma) that requires chronic<br> steroid use<br><br> - Subjects taking corticosteroids during the last 1 week prior treatment, unless<br> administered at a dose equivalent to < 20 mg/day of prednisone<br><br> - Systemic anti-lymphoma therapy within 28 days or use of antibody agents within 4<br> weeks use of radioimmunotherapy within 3 months<br><br> - Known seropositive for or active viral infection with hepatitis B virus (HBV),<br> hepatitis C virus (HCV), human immunodeficiency virus (HIV)<br><br> - Known sensitivity or allergy to murine products<br><br> - Presence or history of central nervous system involvement by lymphoma. Subjects who<br> are at a risk for a thromboembolic event and are not willing to take prophylaxis for<br> it<br><br> - Any condition that places the subject at unacceptable risk if he/she were to<br> participate in the study or that confounds the ability to interpret data from the<br> study<br><br>Other protocol-defined inclusion/exclusion criteria apply
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) for Follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL)
- Secondary Outcome Measures
Name Time Method Overall Survival;Improvement of Response;Overall response rate;Complete response rate;Duration of response;Duration of complete response;Time to next anti-lymphoma treatment;Time to histological transformation;Adverse Events