{"doi":"10.17615/mbvm-5959","title":"Phase 1 trial of rituximab, lenalidomide, and ibrutinib in previously untreated follicular lymphoma: Alliance A051103","abstract":"Chemoimmunotherapy in follicular lymphoma is associated with significant toxicity. Targeted therapies are being investigated as potentially more efficacious and tolerable alternatives for this multiply-relapsing disease. Based on promising activity with rituximab and lenalidomide in previously untreated follicular lymphoma (overall response rate [ORR] 90%-96%) and ibrutinib in relapsed disease (ORR 30%-55%), the Alliance for Clinical Trials in Oncology conducted a phase 1 trial of rituximab, lenalidomide, and ibrutinib. Previously untreated patients with follicular lymphoma received rituximab 375 mg/m 2 on days 1, 8, 15, and 22 of cycle 1 and day 1 of cycles 4, 6, 8, and 10; lenalidomide as per cohort dose on days 1 to 21 of 28 for 18 cycles; and ibrutinib as per cohort dose daily until progression. Dose escalation used a 3+3 design from a starting dose level (DL) of lenalidomide 15 mg and ibrutinib 420 mg (DL0) to DL2 (lenalidomide 20 mg, ibrutinib 560 mg). Twenty-two patients were enrolled; DL2 was determined to be the recommended phase II dose. Although no protocol-defined dose-limiting toxicities were reported, a high incidence of rash was observed (all grades 82%, grade 3 36%). Eleven patients (50%) required dose reduction, 7 because of rash. The ORR for the entire cohort was 95%, and the 12-month progression-free survival was 80% (95% confidence interval, 57%-92%). Five patients developed new malignancies; 3 had known risk factors before enrollment. Given the increased toxicity and required dose modifications, as well as the apparent lack of additional clinical benefit to the rituximab-lenalidomide doublet, further investigation of the regimen in this setting seems unwarranted. The study was registered with www.ClinicalTrials.gov as #NCT01829568.","journal":"UNC Libraries","year":2020,"id":138117,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":0,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9543,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":598844,"name":"Bruce D. Cheson","orcid":"0000-0002-6246-4308","position":1,"is_corresponding":false},{"id":233541,"name":"Matthew S. Davids","orcid":"0000-0003-4529-2003","position":2,"is_corresponding":false},{"id":249996,"name":"Kristie A. Blum","orcid":"0000-0003-4229-2569","position":3,"is_corresponding":false},{"id":598845,"name":"Sonali M. Smith","orcid":"0000-0002-9893-4949","position":4,"is_corresponding":false},{"id":536057,"name":"Steven I. Park","orcid":null,"position":5,"is_corresponding":false},{"id":11098,"name":"Nancy L. Bartlett","orcid":"0000-0001-8470-394X","position":6,"is_corresponding":false},{"id":570267,"name":"Ellis Levine","orcid":"0000-0003-2300-0524","position":7,"is_corresponding":false},{"id":78165,"name":"P. G. Martin","orcid":"0000-0002-5236-3896","position":8,"is_corresponding":false},{"id":581614,"name":"Scott E. Smith","orcid":"0000-0003-3107-3221","position":9,"is_corresponding":false},{"id":233548,"name":"Chaitra S. Ujjani","orcid":"0000-0003-1977-1510","position":10,"is_corresponding":false},{"id":292414,"name":"Lionel D. Lewis","orcid":"0000-0003-1164-5157","position":11,"is_corresponding":false},{"id":491563,"name":"Brandelyn N. Pitcher","orcid":null,"position":12,"is_corresponding":false},{"id":599596,"name":"Myron S. Czuczman","orcid":null,"position":13,"is_corresponding":false},{"id":374167,"name":"Sin‐Ho Jung","orcid":"0000-0002-1473-7236","position":14,"is_corresponding":false},{"id":285253,"name":"John P. Leonard","orcid":"0000-0002-5083-1115","position":0,"is_corresponding":true}],"reference_count":0,"raw_metadata":null,"created_at":"2026-07-18T23:16:59.449905Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}