Relapsed/refractory indolent lymphoma MedDRA version: 20.0 Level: LLT Classification code 10060707 Term: MALT lymphoma System Organ Class: 100000004864 MedDRA version: 20.0 Level: HLT Classification code 10041650 Term: Splenic marginal zone lymphomas System Organ Class: 100000004851 MedDRA version: 20.0 Level: HLT Classification code 10029461 Term: Nodal marginal zone B-cell lymphomas System Organ Class: 100000004851 MedDRA version: 20.0 Level: HLT Classification code 10016903 Term: Follicle
Conditions
Sponsors
Celgene Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age =18 years at the time of signing the ICD - Understand and voluntarily sign an ICD prior to any study related assessments/procedures are conducted. - Histologically confirmed marginal zone lymphoma or follicular lymphoma (grade 1, 2 or 3a) - Previously treated with at least one prior systemic chemotherapy, immunotherapy or chemoimmunotherapy: and must have received at least 2 previous doses of rituximab a) Systemic therapy does not include, for example: i. Local involved field radiotherapy for limited stage disease ii. H. Pylori eradication b) Prior investigational therapies will be allowed provided the subject has received at least one prior systemic therapy as discussed in a) - Documented relapsed, refractory or progressive disease after treatment with systemic therapy, and must not be rituximab-sensitive if had received rituximab or R-chemoregimen therapy refractory a) Relapsed lymphoma: relapsed after initial response of CR to prior therapy. b) Progressive lymphoma: PD after initial response of PR or SD to the prior therapy. c) Refractory lymphoma: Subject who received a non-rituximab containing systemic therapy and who experienced the best response of PD to this therapy is considered to have refractory lymphoma. d) Rituximab-refractoriness is defined as: i. Did not respond (at least a PR) to rituximab or R-chemoregimen therapy and/or ii. Time to disease progression =65 years) yes F.1.3.1 Number of subjects for this age range 245
Exclusion criteria
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, unless administered at a dose equivalent to = 20 mg/day prednisone or prednisolone - Major surgery (excluding lymph node or bone marrow biopsy) within 28 days prior to signing informed consent - Systemic anti-lymphoma therapy within 28 days or use of antibody agents within 8 weeks or use of radioimmunotherapy within 6 months - Known seropositive for or active viral infection with hepatitis B virus (HBV), human immunodeficiency virus (HIV) - Known seropositive for or active infection with hepatitis C virus (HCV) - Hepatitis C virus (HCV) positive subjects with chronic HCV hepatitis or subjects with an active HCV infection requiring anti-viral medication (at time of randomization). (HCV positive subjects who do not have active HCV hepatitis and are otherwise acceptable candidates for the study treatment, as documented by the investigator, are eligible. The Investigator must confirm that the patient does not have an active HCV infection or unacceptable liver damage as documented by one of the following options: liver ultrasound for fibrosis, liver biopsy, zero RNA viral load, or other local practice test.) - Life expectancy Grade 1 - Uncontrolled intercurrent illness. - Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of rituximab plus lenalidomide to rituximab plus placebo in subjects with relapsed/refractory indolent lymphoma.;Secondary Objective: •To compare the safety of rituximab plus lenalidomide versus rituximab plus placebo •To compare the efficacy of rituximab plus lenalidomide versus rituximab plus placebo using other parameters of efficacy: -Durable complete response rate (DCRR), overall response rate (ORR), duration of response (DoR) and duration of complete response (DoCR) by IWG 2007 without PET. -OS, EFS, time to next anti-lymphoma treatment (TTNLT).;Primary end point(s): Progression-free survival (PFS), as assessed by the IRC using the 2007 IWG criteria.;Timepoint(s) of evaluation of this end point: Years 1-3: Every 12 weeks (±1 week); Year 4: Every 16 weeks (±1 week); Year 5 onwards: Every 6 months (± 2 weeks). Assessments will be performed until progression or relapse | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Durable complete response rate (DCRR) • Overall Survival (OS), Overall Response Rate (ORR), Complete Response Rate (CR Rate) Duration of Response (DoR), Duration of Complete Response (DoCR), Event-Free Survival (EFS), Time to Next anti-Lymphoma Treatment (TTNLT), Safety ;Timepoint(s) of evaluation of this end point: Years 1-3: Every 12 weeks (±1 week); Year 4: Every 16 weeks (±1 week); Year 5 onwards: Every 6 months (± 2 weeks). Response assessments will be performed until progression or relapse with continued follow-up for survival and second primary malignancies up to 5 years from last subject randomized. | — |
Countries
Belgium, Brazil, China, Czech Republic, France, Germany, Israel, Italy, Japan, Poland, Portugal, Russian Federation, Spain, Turkey, United Kingdom, United States
Contacts
Public ContactClinicalTrialDisclosure
Celgene Corporation
Outcome results
None listed