{"entity":{"id":"xm01-22","kind":"trial","name":"XM01-22","aka":["XM01 22","ISRCTN08063129"],"tldr":"XM01-22 showed that a weekly injection of epoetin theta, a made-to-order copy of the hormone that tells the marrow to make red blood cells, lifted haemoglobin by a clear margin without a transfusion in almost three quarters of people on nonplatinum chemotherapy, against one quarter on placebo, which helped support its European approval for the anaemia of chemotherapy.","summary":"XM01-22 was a multinational, multicentre, randomised, double-blind, placebo-controlled phase 3 trial of epoetin theta in anaemic adults with solid tumours or non-myeloid haematological malignancies receiving nonplatinum chemotherapy. Patients were randomised to subcutaneous epoetin theta starting at 20,000 IU once weekly or matching placebo for 12 weeks. The primary endpoint was complete haemoglobin response, defined as a haemoglobin increase of at least 2 g/dL without a transfusion in the previous four weeks.\n\nIn the Archives of Drug Information 2011 report, 72.6 percent of patients on epoetin theta and 25.3 percent on placebo had a complete response (P less than 0.0001). Fewer patients on epoetin theta received transfusions after randomisation (13.7 percent versus 25.3 percent, P = 0.0277). Most responders reached their response at the 20,000 IU starting dose. Overall adverse-event frequencies were similar; hypertension was the only adverse event more frequent with epoetin theta (8.4 percent versus 1.1 percent).\n\nThe ISRCTN08063129 record carries the protocol serial number XM01-22, names BioGeneriX AG as sponsor and gives an overall end date of 11 May 2007. The Eporatio product information describes this 186-patient nonplatinum study as the first of the two cancer chemotherapy trials behind the anaemia indication. The programme treats chemotherapy-induced anaemia across mixed tumour types rather than a single corpus cancer, so the record carries no cancer ids.","status":"positive","asOf":"2026-09-24","links":[{"label":"ISRCTN08063129","url":"https://www.isrctn.com/ISRCTN08063129"},{"label":"Archives of Drug Information 2011","url":"https://doi.org/10.1111/j.1753-5174.2011.00035.x"},{"label":"Eporatio EPAR (EMA)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/eporatio"}],"tags":[],"related":[],"cancers":[],"sections":["supportive-care"],"technologies":[],"targets":[],"drugs":["epoetin-theta"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-xm01-22-tjulandin-arch-drug-inf-2011"],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN08063129","phase":"3","setting":"Anaemic adults with solid tumours or non-myeloid haematological malignancies receiving nonplatinum chemotherapy: epoetin theta 20,000 IU subcutaneously once weekly versus placebo for 12 weeks","sponsor":"BioGeneriX","result":"Complete haemoglobin response 72.6% vs 25.3% with placebo (P<0.0001); transfusions after randomisation 13.7% vs 25.3% (P = 0.0277).","yearReported":2011,"enrolled":186,"enrolledBasis":"randomised","enrolledNote":"The Archives of Drug Information 2011 abstract reports 95 patients randomised to epoetin theta and 91 to placebo (186 in total), and the ISRCTN08063129 record gives a target enrolment of 186; the study has no ClinicalTrials.gov record, so there is no NCT enrolment figure to compare.","outcomes":[{"endpoint":"Complete haemoglobin response (increase of at least 2 g/dL without transfusion in the previous 4 weeks)","primary":true,"unit":"%","arms":[{"name":"Epoetin theta 20,000 IU weekly","n":95,"value":72.6},{"name":"Placebo","n":91,"value":25.3}],"p":"<0.0001","source":"https://doi.org/10.1111/j.1753-5174.2011.00035.x"},{"endpoint":"Patients transfused after randomisation","unit":"%","arms":[{"name":"Epoetin theta 20,000 IU weekly","n":95,"value":13.7,"note":"13 patients"},{"name":"Placebo","n":91,"value":25.3,"note":"23 patients"}],"p":"0.0277","source":"https://doi.org/10.1111/j.1753-5174.2011.00035.x"}],"replication":"The companion platinum study XM01-21 (ISRCTN09530309; Tjulandin 2010, three arms with epoetin beta) reported the same direction of effect and is not yet recorded here."},"route":"/trials/xm01-22/","neighbours":{"section":[{"id":"supportive-care","kind":"section","name":"Supportive Care & Survivorship","route":"/fronts/supportive-care/"}],"drug":[{"id":"epoetin-theta","kind":"drug","name":"Epoetin theta","route":"/drugs/epoetin-theta/"}],"paper":[{"id":"paper-xm01-22-tjulandin-arch-drug-inf-2011","kind":"paper","name":"Epoetin theta with a new dosing schedule in anaemic cancer patients receiving nonplatinum-based chemotherapy: a randomised controlled trial (XM01-22)","route":"/key-papers/paper-xm01-22-tjulandin-arch-drug-inf-2011/"}]}}