{"entity":{"id":"nct00718549","kind":"trial","name":"A Study to Assess the Effect of Maintenance Treatment With Rituximab Versus No Treatment in Participants With Progressive B-Cell Chronic Lymphocytic Leukemia (CLL)","aka":[],"tldr":"A phase 3 trial of Cladribine, Cyclophosphamide and Rituximab in Leukaemia, run by Hoffmann-La Roche, completed.","summary":"A Study to Assess the Effect of Maintenance Treatment With Rituximab Versus No Treatment in Participants With Progressive B-Cell Chronic Lymphocytic Leukemia (CLL) is a phase 3 interventional study registered as NCT00718549 by Hoffmann-La Roche, with 128 participants recorded, started 2009-07-21 and reaching its primary completion in 2015-09-14. Interventions recorded: Cladribine, Cyclophosphamide, Rituximab. Conditions recorded: Lymphocytic Leukemia, Chronic.\n\nLinked to the drug Cladribine because the registry names it among its interventions and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00718549","url":"https://clinicaltrials.gov/study/NCT00718549"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["cladribine","cyclophosphamide","rituximab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00718549","phase":"3","setting":"A Randomized, Open Label Study to Assess the Effect of Maintenance Treatment With Mabthera (Rituximab) Versus No Treatment, After Induction Treatment With Rituximab, Cladribine and Cyclophosphamide (RCC) on Progression-Free Survival in Previously Untreated Patients With Progressive B-Cell Chronic Lymphocytic Leukemia","sponsor":"Hoffmann-La Roche","started":"2009-07-21","startedType":"actual","yearReported":2018,"enrolled":128,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-Fee Survival (PFS) Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL","primary":true,"unit":"years","arms":[{"name":"Maintenance Arm: Rituximab","n":33,"note":"Median and Upper Limit could not be calculated due to insufficient number of participants who had an event.; Figures from the ClinicalTrials.gov results section (first posted 2018-08-20), not from a publication"},{"name":"Observation Arm: No Intervention","n":33,"value":2.1,"note":"95% CI 1.9 to NA"},{"name":"All Randomized Participants","n":66,"value":3.1,"note":"95% CI 2.2 to NA"}],"source":"https://clinicaltrials.gov/study/NCT00718549?tab=results"}]},"route":"/trials/nct00718549/","neighbours":{"cancer":[{"id":"leukaemia","kind":"cancer","name":"Leukaemia (all types)","route":"/cancers/leukaemia/"}],"drug":[{"id":"cladribine","kind":"drug","name":"Cladribine","route":"/drugs/cladribine/"},{"id":"cyclophosphamide","kind":"drug","name":"Cyclophosphamide","route":"/drugs/cyclophosphamide/"},{"id":"rituximab","kind":"drug","name":"Rituximab","route":"/drugs/rituximab/"}],"company":[{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}]}}