Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021
ROBUST: A Phase III Study of Lenalidomide Plus R-CHOP Versus Placebo Plus R-CHOP in Previously Untreated Patients With ABC-Type Diffuse Large B-Cell Lymphoma.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 162 papers, 7 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
162 citing papers in PubMed, 7 syntheses or guidelines pooled it, 254 citations in OpenAlex.
- Pola-R-CHP as frontline therapy for diffuse large B-cell lymphoma: a systematic review and meta-analysis of randomized trials and real-world evidence.Blood cancer journal · 2026Pooled it
- SEOM-GOTEL clinical guidelines on diffuse large B-cell lymphoma (update 2025).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025Guideline
- Potential surrogate endpoint for B-cell hematologic malignancy: A systematic review and meta-analysis.Scientific reports · 2025Pooled it
- Patient-Reported Outcomes in Phase 3 Clinical Trials for Blood Cancers: A Systematic Review.JAMA network open · 2024Pooled it
- How to improve RCHOP as frontline therapy for diffuse large B-cell lymphoma: a systematic review and meta-analysis of 21 randomized controlled trials.Annals of hematology · 2024Pooled it
- The management of newly diagnosed large B-cell lymphoma: A British Society for Haematology Guideline.British journal of haematology · 2024Guideline
- Efficacy and safety of lenalidomide in diffuse large B-cell lymphoma: a meta-analysis of randomized controlled trials.Clinical and experimental medicine · 2023Pooled it
- Zanubrutinib combined with R-CHOP in previously untreated diffuse large B-cell lymphoma with specific gene alteration: a phase II study.Blood cancer journal · 2026Trial
- Mecapegfilgrastim for Prophylaxis of Immunochemotherapy-Induced Neutropenia in Patients With Diffuse Large B-Cell Lymphoma: A Multicenter Pilot Trial.Cancer medicine · 2026Trial
- ZR2-miniCHOP for elderly patients with newly diagnosed diffuse large B-cell lymphoma.BMC cancer · 2026Trial
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- A multicenter phase 1/2 trial of lenalidomide and dose-adjusted EPOCH-R in MYC-associated DLBCL.Blood advances · 2025Trial
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- Atezolizumab consolidation in patients with high-risk diffuse large B-cell lymphoma in complete remission after R-CHOP.Blood advances · 2025Trial
- Lenalidomide in combination with rituximab, dexamethasone, high-dose ARA-C and cisplatinum as salvage therapy in refractory or relapsed aggressive B-cell non-hodgkin-lymphoma - an open-label, multicentre phase I/II study (DSHNHL-R6).Annals of hematology · 2025Trial
- The efficacy and safety of ZR2 versus R-CHOP-like for elderly patients with newly diagnosed diffuse large B cell lymphoma: a single-center prospective study in China.Annals of hematology · 2025Trial
- Mosunetuzumab in combination with CHOP in previously untreated DLBCL: safety and efficacy results from a phase 2 study.Blood advances · 2023Trial
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- Central nervous system relapse in younger patients with diffuse large B-cell lymphoma: a LYSA and GLA/DSHNHL analysis.Blood advances · 2023Trial
102 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
30 authors at 19 institutions in 10 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposePatients with the activated B-cell-like (ABC) subtype of diffuse large B-cell lymphoma (DLBCL) historically showed inferior survival with standard rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). Phase II studies demonstrated that adding the immunomodulatory agent lenalidomide to R-CHOP improved outcomes in ABC-type DLBCL. The goal of the global, phase III ROBUST study was to compare lenalidomide plus R-CHOP (R2-CHOP) with placebo/R-CHOP in previously untreated, ABC-type DLBCL.
methodsHistology and cell-of-origin type were prospectively analyzed by central pathology prior to random assignment and study treatment. Patients with ABC-DLBCL received lenalidomide oral 15 mg/d, days 1-14/21 plus standard R-CHOP21 versus placebo/R-CHOP21 for six cycles. The primary end point was progression-free survival (PFS) per independent central radiology review.
resultsA total of 570 patients with ABC-DLBCL (n = 285 per arm) were stratified by International Prognostic Index score, age, and bulky disease, and randomly assigned to R2-CHOP or placebo/R-CHOP. Baseline demographics were similar between arms. Most patients completed six cycles of treatment: 74% R2-CHOP and 84% placebo/R-CHOP. The most common grade 3/4 adverse events for R2-CHOP versus placebo/R-CHOP were neutropenia (60%
conclusionROBUST is the first DLBCL phase III study to integrate biomarker-driven identification of eligible ABC patients. Although the ROBUST trial did not meet the primary end point of PFS in all patients, the safety profile of R2-CHOP was consistent with individual treatments with no new safety signals.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.