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.
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.
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
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