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HEALTH PROFESSIONAL · SOURCE READING

Lenalidomide and rituximab

Source: Indolent B-Cell Non-Hodgkin Lymphoma Treatment (PDQ®)–Health Professional Version, National Cancer Institute.

Source updated: May 14, 2025 · Captured 2026-09-09.

Selected source text with whitespace normalised. This Triangle page is not an NCI PDQ summary. Independent clinical review is pending.

Context: Treatment of Indolent, Noncontiguous Stage II/III/IV B-Cell Non-Hodgkin Lymphoma / Treatment Options for Indolent, Noncontiguous Stage II/III/IV B-Cell NHL

The combination of the immunomodulating agent lenalidomide with rituximab (the so-called R2 regimen) has been proposed as an alternative regimen to combinations involving cytotoxic agents and their subsequent short- and long-term toxicities.

Evidence (lenalidomide and rituximab):

In a randomized prospective trial (RELEVANCE [NCT01650701]) of 1,030 patients with previously untreated follicular lymphoma, rituximab plus lenalidomide for 18 months was compared with rituximab plus chemotherapy (usually R-CHOP).[41,42] All patients received rituximab maintenance for up to 2 years.

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In a randomized prospective trial (RELEVANCE [NCT01650701]) of 1,030 patients with previously untreated follicular lymphoma, rituximab plus lenalidomide for 18 months was compared with rituximab plus chemotherapy (usually R-CHOP).[41,42] All patients received rituximab maintenance for up to 2 years.

With a median follow-up of 72 months, the 6-year PFS rates (60% and 59%) and 3-year OS rates (89%) were identical (HR for PFS, 1.03; 95% CI, 0.84–1.27; P = .78) (HR for OS was not reported).[41,42][Level of evidence A1]

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In a randomized prospective trial (RELEVANCE [NCT01650701]) of 1,030 patients with previously untreated follicular lymphoma, rituximab plus lenalidomide for 18 months was compared with rituximab plus chemotherapy (usually R-CHOP).[41,42] All patients received rituximab maintenance for up to 2 years.

This trial established that the R2 regimen is as effective as rituximab plus cytotoxic chemotherapy options. The transformation rate to aggressive lymphoma per year was 0.68% in the R2 group and 0.45% in the R-chemotherapy group. With a median follow-up of 72 months, there were no new safety signals.[42]

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In a randomized prospective trial of 358 patients with resistant/refractory indolent lymphoma (usually follicular lymphoma), the R2 regimen was compared with rituximab alone.[43]

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In a randomized prospective trial of 358 patients with resistant/refractory indolent lymphoma (usually follicular lymphoma), the R2 regimen was compared with rituximab alone.[43]

With a median follow-up of 28 months, the median PFS was 39.4 months for R2 and 14.1 months for rituximab alone (P < .0001), with no difference in OS.[43][Level of evidence B1]

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Studies cited in this source section

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Preserved source evidence · Independent clinical review pending · Not medical advice