relapsed/refractory follicular, marginal zone or mantle cell lymphoma
Conditions
Sponsors
Celgene Corporation
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 220 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 280
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy and safety of lenalidomide plus rituximab combination maintenance therapy (for 18 cycles) followed by optional lenalidomide single-agent maintenance (to progression) versus rituximab single-agent maintenance (for 18 cycles) after 12 cycles of induction therapy with lenalidomide plus rituximab, in subjects with relapsed/refractory follicular lymphoma grades 1-3b, transformed follicular lymphoma, marginal zone lymphoma or mantle cell lymphoma.;Secondary Objective: The secondary objectives of the study are: 1. To compare the safety of lenalidomide plus rituximab combination maintenance therapy (for 18 cycles) followed by optional lenalidomide single-agent maintenance (to progression) versus rituximab single-agent maintenance (for 18 cycles) after 12 cycles of induction therapy with lenalidomide plus rituximab. 2. To compare other parameters of efficacy (OS, IOR, ORR, CRR, DOR, DOCR, TTNLT, TTHT) of lenalidomide plus rituximab combination maintenance therapy (for 18 cycles) followed by optional lenalidomide single-agent maintenance (to progression) versus rituximab single-agent maintenance (for 18 cycles) after 12 cycles of induction therapy with lenalidomide plus rituximab.;Primary end point(s): Progression free survival (PFS) for Follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL);Timepoint(s) of evaluation of this end point: At 3 cycles (84 days +/- 2 weeks) At 6 cycles (168 days +/- 2 weeks) Every 6 cycles (168 days +/- 2 weeks) up to five years Thereafter annually (+/- 3 weeks) up to Progession Disease, or initiation of new anti-lymphome therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints will include: Overall Survival (OS) Improvement of Response (IOR) Overall Response Rate (ORR) Complete Response Rate (CRR) Duration of Response (DOR) Duration of Complete Response (DOCR) Time to Histological Transformation (TTHT) Time to Next Anti-Lymphoma Treatment (TTNLT) Safety;Timepoint(s) of evaluation of this end point: At 3 cycles (84 days +/- 2 weeks) At 6 cycles (168 days +/- 2 weeks) Every 6 cycles (168 days +/- 2 weeks) up to five years Thereafter annually (+/- 3 weeks) up to Progession Disease, or initiation of new anti-lymphome therapy | — |
Countries
Germany, United States
Contacts
Public ContactGSM-CT
Celgene Corporation
Outcome results
None listed