Phase 3
Completed N=358
Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma)
Lymphoma, Non-Hodgkin
Source: ClinicalTrials.gov NCT01938001 ↗
Enrolled (actual)
358
Serious AEs
19.7%
Results posted
Aug 2019
Primary outcomePrimary: Kaplan Meier Estimate of Progression Free Survival Assessed by the Independent Review Committee (IRC) According to the 2007 International Working Group Response Criteria (IWGRC) — 39.4; 14.1 months — p=< 0.0001
◆ Published Evidence
Highly cited
422citations · ~60 / year
AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma.
Summary
This double-blind randomized, parallel group study will evaluate the efficacy and safety of lenalidomide (Revlimid, CC-5013) in combination with rituximab (MabThera/Rituxan) in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma. Patients will be randomized to receive either lenalidomide or placebo for twelve 28-day cycles in combination with rituximab. Anticipated time on study treatment is 1 year.
Linked Publications (2)
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AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma.
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Lenalidomide Plus Rituximab for Relapsed/Refractory Indolent Non-Hodgkin Lymphoma: 5-Year Follow-Up and Subgroup Analyses From the Phase III AUGMENT Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kaplan Meier Estimate of Progression Free Survival Assessed by the Independent Review Committee (IRC) According to the 2007 International Working Group Response Criteria (IWGRC) |
39.4; 14.1 | < 0.0001 sig |
| SECONDARY Durable Complete Response Rate (DCCR) as Assessed by the IRC According to the 2007 IWGRC |
25.3; 11.1 | 0.0006 sig |
| SECONDARY Kaplan-Meier Estimate of Overall Survival (OS) |
NA; NA | — |
| SECONDARY Percentage of Participants With an Objective Response as Assessed by the IRC According to the 2007 IWGRC |
77.5; 53.3 | < 0.0001 sig |
| SECONDARY Percentage of Participants With a Best Response of Complete Response as Assessed by the IRC According to the 2007 IWGRC |
33.7; 18.3 | = 0.0010 sig |
| SECONDARY Kaplan-Meier Estimate of Duration of Objective Response as Assessed by the IRC According to the 2007 IWGRC |
36.6; 21.7 | 0.0015 sig |
| SECONDARY Kaplan-Meier Estimate of Duration of Complete Response (DOCR) as Assessed by the IRC According to the 2007 IWGRC |
NA; NA | 0.2993 |
| SECONDARY Kaplan Meier Estimate of Event Free Survival as Assessed by the IRC According to the 2007 IWGRC |
27.6; 13.9 | < 0.0001 sig |
| SECONDARY Kaplan Meier Estimate of Time to Next Anti-Lymphoma Treatment (TTNLT) |
73.1; 31.8 | <0.0001 sig |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
174; 173; 159; 118; 134; 105 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years at the time of signing the informed consent document.
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
- Histologically confirmed marginal zone lymphoma or follicular lymphoma (grade 1, 2 or 3a; CD20+ by flow cytometry or histochemistry).
- Previously treated with at least one prior systemic chemotherapy, immunotherapy or chemoimmunotherapy and have received at least 2 previous doses of rituximab.
- Documented relapsed, refractory or progressive disease after treatment with systemic therapy and must not be rituximab-refractory.
- Investigator considers rituximab monotherapy appropriate.
- Bi-dimensionally measurable disease on cross sectional imaging by X-ray computed tomography (CT) or magnetic resonance imaging (MRI).
- Need of treatment for relapsed, progressed or refractory disease as assessed by the investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Adequate bone marrow function.
- Willingness to follow study visit schedule, pregnancy precautions and other protocol requirements.
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 prior to study treatment, unless administered at a dose equivalent to Grade 1.
- 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.
- Uncontrolled intercurrent illness.
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document.
- 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.
Data sourced from ClinicalTrials.gov (NCT01938001) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.