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Clinical Trial
. 2019 May 10;37(14):1188-1199.
doi: 10.1200/JCO.19.00010. Epub 2019 Mar 21.

AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma

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Free PMC article
Clinical Trial

AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma

John P Leonard et al. J Clin Oncol. .
Free PMC article

Abstract

Purpose: Patients with indolent non-Hodgkin lymphoma typically respond well to first-line immunochemotherapy. At relapse, single-agent rituximab is commonly administered. Data suggest the immunomodulatory agent lenalidomide could increase the activity of rituximab.

Methods: A phase III, multicenter, randomized trial of lenalidomide plus rituximab versus placebo plus rituximab was conducted in patients with relapsed and/or refractory follicular or marginal zone lymphoma. Patients received lenalidomide or placebo for 12 cycles plus rituximab once per week for 4 weeks in cycle 1 and day 1 of cycles 2 through 5. The primary end point was progression-free survival per independent radiology review.

Results: A total of 358 patients were randomly assigned to lenalidomide plus rituximab (n = 178) or placebo plus rituximab (n = 180). Infections (63% v 49%), neutropenia (58% v 23%), and cutaneous reactions (32% v 12%) were more common with lenalidomide plus rituximab. Grade 3 or 4 neutropenia (50% v 13%) and leukopenia (7% v 2%) were higher with lenalidomide plus rituximab; no other grade 3 or 4 adverse event differed by 5% or more between groups. Progression-free survival was significantly improved for lenalidomide plus rituximab versus placebo plus rituximab, with a hazard ratio of 0.46 (95% CI, 0.34 to 0.62; P < .001) and median duration of 39.4 months (95% CI, 22.9 months to not reached) versus 14.1 months (95% CI, 11.4 to 16.7 months), respectively.

Conclusion: Lenalidomide improved efficacy of rituximab in patients with recurrent indolent lymphoma, with an acceptable safety profile.

Trial registration: ClinicalTrials.gov NCT01938001.

Figures

FIG 1.
FIG 1.
Lenalidomide plus rituximab and placebo plus rituximab group CONSORT diagram (flow of patients from enrollment to analysis). AE, adverse event; ITT, intention to treat.
FIG 2.
FIG 2.
Progression-free survival (PFS) and overall survival (OS) as assessed by independent review committee in the intention-to-treat population: (A) progression-free survival; (B) overall survival.
FIG 3.
FIG 3.
Forest plot: subgroup analyses of progression-free survival. GELF, Groupe d’Etude des Lymphomes Folliculaires; HR, hazard ratio.
FIG A1.
FIG A1.
Progression-free survival (PFS) as assessed by investigator in the intention-to-treat population.
FIG A2.
FIG A2.
Duration of response as assessed by independent review committee in the intention-to-treat population.
FIG A3.
FIG A3.
Event-free survival as assessed by independent review committee in the intention-to-treat population.
FIG A4.
FIG A4.
Time to next antilymphoma treatment in the intention-to-treat population.
FIG A5.
FIG A5.
Time to next antilymphoma chemotherapy in the intention-to-treat population.
FIG A6.
FIG A6.
Progression-free survival incorporating next antilymphoma treatment (PFS2) in the intention-to-treat population.
FIG A7.
FIG A7.
Overall survival (OS) in patients with follicular lymphoma in the intention-to-treat population.
FIG A8.
FIG A8.
Overall survival (OS) in patients with marginal zone lymphoma in the intention-to-treat population.

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