Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma. (MAGNIFY)
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ClinicalTrials.gov Identifier: NCT01996865 |
Recruitment Status :
Active, not recruiting
First Posted : November 27, 2013
Last Update Posted : August 5, 2021
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Condition or disease | Intervention/treatment | Phase |
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Lymphoma, Non-Hodgkin | Drug: Lenalidomide Drug: Rituximab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 507 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3B Randomized Study of Lenalidomide (CC-5013) Plus Rituximab Maintenance Therapy Followed by Lenalidomide Single-Agent Maintenance Versus Rituximab in Subjects With Relapsed/Refractory Follicular, Marginal Zone, or Mantle Cell Lymphoma |
Actual Study Start Date : | April 28, 2014 |
Estimated Primary Completion Date : | April 8, 2023 |
Estimated Study Completion Date : | July 15, 2024 |

Arm | Intervention/treatment |
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Experimental: Arm A: Lenalidomide + rituximab followed by lenalidomide
Induction Period (12 cycles): Lenalidomide 20mg (10 mg if creatinine clearance ≥ 30 mL/min but < 60mL/min) by mouth (PO) daily (QD) on Days 1 to 21 of every 28-day cycle during cycles 1 through 12 and rituximab 375mg/m^2 intraveneously (IV) every week in Cycle 1 on Days 1, 8, 15, and 22 and on Day 1 of every 28-day cycle during cycles 3, 5, 7, 9, and 11, followed by a Maintenance Period (lasting 18 Cycles) that includes Lenalidomide 10 mg PO QD on Days 1 to 21 of every 28-day cycle during cycles 13 to 30 and rituximab 375 mg/m^2 IV on Day 1 of every 28-day cycle during cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29 followed by a Maintenance Period (up to Progressive Disease) receiving Lenalidomide 10mg PO QD on Days 1 through 21 of every 28 day cycle until the disease progresses
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Drug: Lenalidomide
Other Name: CC-5013, Revlimid Drug: Rituximab Other Name: Rituxan |
Active Comparator: Arm B: Lenalidomide + rituximab followed by rituximab
Induction Period (12 Cycles): Lenalidomide 20 mg PO QD (10 mg if creatinine clearance ≥ 30 mL/min but < 60 mL/min) on Days 1 to 21 of every 28-day cycle during cycles 1 to 12 and rituximab 375 mg/m^2 IV every week in cycle 1 on Days 1, 8, 15, and 22 and on Day 1 of every 28-day cycle during cycles 3, 5, 7, 9, and 11, followed by a Maintenance Period for 18 Cycles that includes: Rituximab 375 mg/m^2 IV on Day 1 of every 28-day cycle during cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29
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Drug: Lenalidomide
Other Name: CC-5013, Revlimid Drug: Rituximab Other Name: Rituxan |
- Progression free survival (PFS) for Follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL) [ Time Frame: Up to 8 years ]Progression free survival is defined as the time from randomization into the study to the first observation of documented disease progression or death due to any cause
- Adverse Events [ Time Frame: Up to 8 years ]Number of participants with adverse events
- Complete response rate [ Time Frame: 8 years ]Complete response rate is defined as proportion of subjects with a best response of at least unconfirmed complete remission (including complete remission and unconfirmed complete remission)
- Overall response rate [ Time Frame: 8 years ]Overall response rate is defined as proportion of subjects with a best response of at least partial remission (including partial remission, complete remission and unconfirmed complete remission).
- Duration of response [ Time Frame: 8 years ]Duration of response is defined as the time from the initial response (at least partial remission) to documented disease progression
- Duration of complete response [ Time Frame: 8 years ]Duration of complete response is defined as the time from the first evidence of CR/CRu to documented disease progression
- Time to the next anti-lymphoma treatment [ Time Frame: 8 years ]Duration of response is defined as time from initial response of at least a PR to documented progression/relapse
- Time to treatment failure [ Time Frame: 8 years ]Time to treatment failure is defined as the time from the date of randomization to discontinuation of treatment for any reason, including disease progression, treatment toxicity or death
- Time to histological transformation [ Time Frame: 8 years ]Time to histological transformation is defined as the time from the date of randomization to time to histological transformation as measured based on documentation of histological transformation

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996865

Study Director: | Mecide Gharibo, MD | Celgene |
Responsible Party: | Celgene |
ClinicalTrials.gov Identifier: | NCT01996865 |
Other Study ID Numbers: |
CC-5013-NHL-008 |
First Posted: | November 27, 2013 Key Record Dates |
Last Update Posted: | August 5, 2021 |
Last Verified: | August 2021 |
Lymphoma, Mantle cell Lymphoma, Follicular Lymphoma, Marginal zone Lymphoma, Lenalidomide treatment, rituximab treatment, Non Hodgkins Lymphoma |
Lymphoma Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Rituximab |
Lenalidomide Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |