{"entity":{"id":"mitoxantrone","kind":"drug","name":"Mitoxantrone","aka":[],"tldr":"Mitoxantrone is a blue chemotherapy infusion used with cytarabine for acute myeloid leukaemia and, historically, to relieve pain in advanced prostate cancer; it is also licensed for multiple sclerosis.","summary":"Mitoxantrone was approved in 1987 for acute non-lymphocytic leukaemia in adults in combination with other agents and later for pain relief in advanced hormone-refractory prostate cancer with corticosteroids, where it improved palliative endpoints without extending survival and was then displaced by docetaxel (TAX 327). It remains in AML salvage regimens such as MEC and FLAG-Ida alternatives and in some lymphoma protocols, and carries a separate indication for progressive multiple sclerosis. Cardiotoxicity (lifetime dose limits and ejection fraction monitoring), secondary acute leukaemia and blue-green discolouration of urine and sclerae are characteristic.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Mitoxantrone","links":[{"label":"US label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=mitoxantrone"},{"label":"NCI drug page","url":"https://www.cancer.gov/about-cancer/treatment/drugs/mitoxantronehydrochloride"}],"tags":["nci-list","generic"],"related":[],"cancers":["aml","prostate"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["nct03591510","nct04668690","nct03182244"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Novantrone (historic)","modality":"Anthracenedione (topoisomerase II inhibitor)","mechanism":"Synthetic anthracenedione that intercalates DNA, causes cross-links and strand breaks and inhibits topoisomerase II; less cardiotoxic per dose than anthracyclines but cumulative limits still apply.","approvals":[{"region":"US","year":1987,"indication":"Acute non-lymphocytic leukaemia in adults (combination); later hormone-refractory prostate cancer pain (with corticosteroids) and multiple sclerosis"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/mitoxantrone/","neighbours":{"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"},{"id":"aml-paediatric","kind":"cancer","name":"Acute myeloid leukaemia in children","route":"/cancers/aml-paediatric/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"},{"id":"all-paediatric-relapsed","kind":"cancer","name":"Relapsed and refractory acute lymphoblastic leukaemia in children","route":"/cancers/all-paediatric-relapsed/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"topoisomerase-inhibitors","kind":"technology","name":"Topoisomerase-I inhibitors (and ADC payloads)","route":"/technologies/topoisomerase-inhibitors/"}],"trial":[{"id":"nct03591510","kind":"trial","name":"A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML","route":"/trials/nct03591510/"},{"id":"nct03182244","kind":"trial","name":"A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation","route":"/trials/nct03182244/"},{"id":"nct04293562","kind":"trial","name":"A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations","route":"/trials/nct04293562/"},{"id":"ukallr3","kind":"trial","name":"ALL R3 (UKALLR3)","route":"/trials/ukallr3/"},{"id":"nct04668690","kind":"trial","name":"Clinical Study of Mitoxantrone Hydrochloride Liposome Injection vs. Chidamide in Patients With Relapsed/Refractory PTCL","route":"/trials/nct04668690/"},{"id":"nct00003436","kind":"trial","name":"Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myeloid Leukemia","route":"/trials/nct00003436/"},{"id":"nct00002719","kind":"trial","name":"Combination Chemotherapy With or Without G-CSF in Treating Older Patients With Acute Myeloid Leukemia","route":"/trials/nct00002719/"},{"id":"nct00002658","kind":"trial","name":"Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia","route":"/trials/nct00002658/"},{"id":"intreall-sr-2010","kind":"trial","name":"IntReALL SR 2010","route":"/trials/intreall-sr-2010/"},{"id":"nct02521493","kind":"trial","name":"Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome","route":"/trials/nct02521493/"},{"id":"nct02072811","kind":"trial","name":"Role of the Therapy Tailored to Risk Factors in Treating Adult Patients (≤60) With Acute Myeloid Leukemia","route":"/trials/nct02072811/"},{"id":"swog-9916","kind":"trial","name":"SWOG 9916","route":"/trials/swog-9916/"},{"id":"tax-327","kind":"trial","name":"TAX 327","route":"/trials/tax-327/"},{"id":"nct01700946","kind":"trial","name":"Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma","route":"/trials/nct01700946/"},{"id":"nct00136084","kind":"trial","name":"Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia","route":"/trials/nct00136084/"},{"id":"tropic","kind":"trial","name":"TROPIC","route":"/trials/tropic/"}],"paper":[{"id":"paper-all-r3-mitoxantrone-relapsed-childhood-all-parker-lancet-2010","kind":"paper","name":"ALL R3: mitoxantrone versus idarubicin in first relapse of childhood acute lymphoblastic leukaemia","route":"/key-papers/paper-all-r3-mitoxantrone-relapsed-childhood-all-parker-lancet-2010/"},{"id":"paper-petrylak-swog-9916-docetaxel-estramustine-nejm-2004","kind":"paper","name":"SWOG 9916: docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer","route":"/key-papers/paper-petrylak-swog-9916-docetaxel-estramustine-nejm-2004/"},{"id":"paper-tannock-tax-327-docetaxel-prednisone-nejm-2004","kind":"paper","name":"TAX 327: docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer","route":"/key-papers/paper-tannock-tax-327-docetaxel-prednisone-nejm-2004/"},{"id":"paper-de-bono-tropic-cabazitaxel-lancet-2010","kind":"paper","name":"TROPIC: prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel","route":"/key-papers/paper-de-bono-tropic-cabazitaxel-lancet-2010/"}]}}