{"entity":{"id":"ptld-1","kind":"trial","name":"PTLD-1","aka":["PTLD-1/3","PTLD-1 RSST","PTLD-1 risk-stratified sequential treatment"],"tldr":"PTLD-1 established how to treat lymphoma that arises after an organ transplant: start with the antibody rituximab alone, and use how well the patient responds to decide whether to continue rituximab or move to chemotherapy; seven in ten reached complete remission and patients lived a median of more than six years.","summary":"PTLD-1 was an international prospective phase 2 trial coordinated from Charite Berlin in adults with CD20-positive post-transplant lymphoproliferative disorder after solid organ transplantation that had not responded to reduced immunosuppression. The original protocol gave sequential rituximab then CHOP to all; the risk-stratified amendment (PTLD-1/3) gave four weekly rituximab infusions and then, in patients with a complete response, four further rituximab doses, while all others received four cycles of R-CHOP with G-CSF support. The primary endpoint was the overall response rate.\n\nAmong 126 patients in the risk-stratified analysis, 111 (88 percent) responded and 88 (70 percent) reached complete remission; the three-year response duration estimate was 82 percent and median overall survival 6.6 years, with grade 3 or 4 infections in 34 percent and treatment-related mortality of 8 percent. Response to rituximab induction remained prognostic despite stratification. The corpus's post-transplant lymphoproliferative disorder page describes rituximab consolidation alone for complete responders and R-CHOP for the rest on this evidence.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00590447","url":"https://clinicaltrials.gov/study/NCT00590447"}],"tags":["soc-trials"],"related":[],"cancers":["post-transplant-lymphoproliferative-disorder","non-hodgkin-lymphoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["rituximab","cyclophosphamide","doxorubicin","vincristine","prednisone","filgrastim"],"companies":[],"institutions":["charite"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-ptld-1-risk-stratified-sequential-treatment-trappe-jco-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00590447","phase":"2","setting":"CD20-positive post-transplant lymphoproliferative disorder after solid organ transplantation, unresponsive to reduction of immunosuppression: four weekly doses of rituximab, then consolidation chosen by response, four further rituximab doses for patients in complete remission and four cycles of R-CHOP for everyone else (risk-stratified sequential treatment)","sponsor":"Charite University, Berlin, Germany","result":"Overall response 88 percent and complete remission 70 percent with risk-stratified sequential treatment; three-year response duration 82 percent; median overall survival 6.6 years; treatment-related mortality 8 percent.","yearReported":2017,"enrolled":152,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall response rate (complete or partial response after risk-stratified sequential treatment)","primary":true,"unit":"%","arms":[{"name":"Rituximab induction then rituximab or R-CHOP consolidation by response","n":126,"value":88,"note":"95% CI 81 to 93"}],"source":"https://doi.org/10.1200/JCO.2016.69.3564"},{"endpoint":"Complete response rate","unit":"%","arms":[{"name":"Rituximab induction then rituximab or R-CHOP consolidation by response","n":126,"value":70,"note":"95% CI 61 to 77"}],"source":"https://doi.org/10.1200/JCO.2016.69.3564"},{"endpoint":"Response duration at 3 years","unit":"%","arms":[{"name":"Rituximab induction then rituximab or R-CHOP consolidation by response","n":126,"value":82,"note":"95% CI 74 to 90"}],"source":"https://doi.org/10.1200/JCO.2016.69.3564"},{"endpoint":"Overall survival","unit":"years","arms":[{"name":"Rituximab induction then rituximab or R-CHOP consolidation by response","n":126,"value":6.6,"note":"Median; 95% CI 5.5 to 7.6 years"}],"source":"https://doi.org/10.1200/JCO.2016.69.3564"},{"endpoint":"Treatment-related mortality","unit":"%","arms":[{"name":"Rituximab induction then rituximab or R-CHOP consolidation by response","n":126,"value":8,"note":"95% CI 5 to 14; grade 3 or 4 infections 34 percent"}],"source":"https://doi.org/10.1200/JCO.2016.69.3564"}]},"route":"/trials/ptld-1/","neighbours":{"cancer":[{"id":"non-hodgkin-lymphoma","kind":"cancer","name":"Non-Hodgkin lymphoma (all types)","route":"/cancers/non-hodgkin-lymphoma/"},{"id":"post-transplant-lymphoproliferative-disorder","kind":"cancer","name":"Post-transplant lymphoproliferative disorder (PTLD)","route":"/cancers/post-transplant-lymphoproliferative-disorder/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"cyclophosphamide","kind":"drug","name":"Cyclophosphamide","route":"/drugs/cyclophosphamide/"},{"id":"doxorubicin","kind":"drug","name":"Doxorubicin","route":"/drugs/doxorubicin/"},{"id":"filgrastim","kind":"drug","name":"Filgrastim (G-CSF)","route":"/drugs/filgrastim/"},{"id":"prednisone","kind":"drug","name":"Prednisone","route":"/drugs/prednisone/"},{"id":"rituximab","kind":"drug","name":"Rituximab","route":"/drugs/rituximab/"},{"id":"vincristine","kind":"drug","name":"Vincristine","route":"/drugs/vincristine/"}],"institution":[{"id":"charite","kind":"institution","name":"Charité Universitätsmedizin Berlin","route":"/institutions/charite/"}],"paper":[{"id":"paper-ptld-1-risk-stratified-sequential-treatment-trappe-jco-2017","kind":"paper","name":"PTLD-1: response to rituximab induction as a predictive marker allowing stratification into rituximab or R-CHOP consolidation in B-cell post-transplant lymphoproliferative disorder","route":"/key-papers/paper-ptld-1-risk-stratified-sequential-treatment-trappe-jco-2017/"}]}}