Study of combination of rituximab and lenalidomide treatment in patients with recurrent or unresponsive indolent (slow growing) lymphoma who have been treated previously

Phase 1

• Conditions: Relapsed/refractory indolent lymphoma; MedDRA version: 16.0Level: LLTClassification code 10060707Term: MALT lymphomaSystem Organ Class: 100000004864; MedDRA version: 16.0Level: HLTClassification code 10041650Term: Splenic marginal zone lymphomasSystem Organ Class: 100000004851; MedDRA version: 16.0Level: HLTClassification code 10029461Term: Nodal marginal zone B-cell lymphomasSystem Organ Class: 100000004851; MedDRA version: 16.0Level: HLTClassification code 10016903Term: Follicle centre lymphomas, follicular grade I, II, IIISystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-001245-14-ES
• Lead Sponsor: Celgene Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-08
• Last Update Posted: 25 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

- Age >= 18 years
- Histologically confirmed marginal zone lymphoma or follicular lymphoma (grade 1, 2 or 3a)
- Documented relapsed, refractory or progressive disease after treatment with systemic therapy
- Rituximab naïve or rituximab sensitive
- Investigator considers rituximab monotherapy appropriate
- 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 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 245

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
- 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), 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br>?To compare the efficacy of rituximab plus lenalidomide versus rituximab plus placebo using other parameters of efficacy:<br> -CR rate, durable complete response rate, overall response rate (ORR), and duration of response (DOR) by IWG 2007 without PET.<br> -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); <br>Year 4: Every 16 weeks (+-1 week); <br>Year 5 onwards: Every 6 months (+- 2 weeks). <br>Assessments will be performed until progression or relapse

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): ? Durable complete response rate as assessed by the IRC<br>? Overall Survival (OS), Overall Response Rate (ORR), Duration of Response (DOR), 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);<br>Year 4: Every 16 weeks (+-1 week); <br>Year 5 onwards: Every 6 months (+- 2 weeks). <br>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.