{"id":"methotrexate-delay","safety":{"commonSideEffects":[{"rate":"10-30%","effect":"Nausea"},{"rate":"5-20%","effect":"Vomiting"},{"rate":"5-15%","effect":"Diarrhea"},{"rate":"5-10%","effect":"Fatigue"},{"rate":"5-10%","effect":"Hair loss"},{"rate":"2-5%","effect":"Liver enzyme elevation"},{"rate":"<2%","effect":"Bone marrow suppression"},{"rate":"<1%","effect":"Pancytopenia"},{"rate":"<1%","effect":"Alopecia"},{"rate":"<1%","effect":"Neutropenia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"This action leads to the inhibition of rapidly dividing cells, such as cancer cells and certain immune cells. Methotrexate also has anti-inflammatory properties, which contribute to its therapeutic effects in conditions like rheumatoid arthritis.","oneSentence":"Methotrexate is an antimetabolite that inhibits dihydrofolate reductase, disrupting DNA synthesis and cell division.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:21:02.160Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Treatment of certain types of cancer, including leukemia and lymphoma, and autoimmune diseases like rheumatoid arthritis and psoriasis"},{"name":"Prevention of organ transplant rejection"}]},"trialDetails":[{"nctId":"NCT05681260","phase":"PHASE3","title":"Capizzi Escalating Methotrexate Versus High Dose Methotrexate in Children With Newly Diagnosed T-cell Lymphoblastic Lymphoma (T-LBL)","status":"RECRUITING","sponsor":"Children's Cancer Group, China","startDate":"2023-02-06","conditions":"T-cell Lymphoblastic Lymphoma","enrollment":200},{"nctId":"NCT02114229","phase":"PHASE2","title":"Phase 2 Study of Alisertib Therapy for Rhabdoid Tumors","status":"ACTIVE_NOT_RECRUITING","sponsor":"St. Jude Children's Research Hospital","startDate":"2014-05-14","conditions":"Malignant Rhabdoid Tumor, Atypical Teratoid Rhabdoid Tumor","enrollment":125},{"nctId":"NCT07443592","phase":"NA","title":"Treatment for Ph-negative ALL for Adults up to 65 Years","status":"NOT_YET_RECRUITING","sponsor":"PETHEMA Foundation","startDate":"2026-03-06","conditions":"Acute Lymphoblastic Leukemia","enrollment":330},{"nctId":"NCT03150693","phase":"PHASE3","title":"Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia","status":"SUSPENDED","sponsor":"Alliance for Clinical Trials in Oncology","startDate":"2017-09-20","conditions":"B Acute Lymphoblastic Leukemia","enrollment":310},{"nctId":"NCT05656248","phase":"PHASE2","title":"Study of CPX-351 (VYXEOS) in Individuals < 22 Years With Secondary Myeloid Neoplasms","status":"ACTIVE_NOT_RECRUITING","sponsor":"St. Jude Children's Research Hospital","startDate":"2023-01-17","conditions":"Myeloid Neoplasm","enrollment":25},{"nctId":"NCT00602667","phase":"PHASE2","title":"Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"St. Jude Children's Research Hospital","startDate":"2007-12-17","conditions":"Brain and Central Nervous System Tumors","enrollment":293},{"nctId":"NCT03571321","phase":"PHASE1","title":"Ruxolitinib and Chemotherapy in Adolescents and Young Adults With Ph-like Acute Lymphoblastic Leukemia","status":"RECRUITING","sponsor":"University of Chicago","startDate":"2019-05-28","conditions":"Acute Lymphoblastic Leukemia, ALL, Childhood, ALL","enrollment":15},{"nctId":"NCT02112916","phase":"PHASE3","title":"Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2014-10-04","conditions":"Adult T Acute Lymphoblastic Leukemia, Ann Arbor Stage II Adult Lymphoblastic Lymphoma, Ann Arbor Stage II Childhood Lymphoblastic Lymphoma","enrollment":847},{"nctId":"NCT02883049","phase":"PHASE3","title":"Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2012-02-29","conditions":"B Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, BCR-ABL1-Like, Central Nervous System Leukemia","enrollment":5949},{"nctId":"NCT07108530","phase":"PHASE2","title":"Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myeloid Leukemia: Multicenter Study","status":"RECRUITING","sponsor":"Shanxi Bethune Hospital","startDate":"2025-08-06","conditions":"Acute Myeloid Leukemia","enrollment":50},{"nctId":"NCT07059156","phase":"PHASE2, PHASE3","title":"Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL","status":"RECRUITING","sponsor":"Shanxi Bethune Hospital","startDate":"2025-06-01","conditions":"Acute Lymphoblastic Leukemia, Adult","enrollment":50},{"nctId":"NCT06099366","phase":"PHASE2","title":"Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children","status":"RECRUITING","sponsor":"Hee Young Ju","startDate":"2024-03-05","conditions":"Lymphoblastic Leukemia in Children","enrollment":116},{"nctId":"NCT00408005","phase":"PHASE3","title":"Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2007-01-30","conditions":"T Acute Lymphoblastic Leukemia, T Lymphoblastic Lymphoma","enrollment":1895},{"nctId":"NCT01190930","phase":"PHASE3","title":"Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Children's Oncology Group","startDate":"2010-08-09","conditions":"Acute Lymphoblastic Leukemia, Adult B Lymphoblastic Lymphoma, Ann Arbor Stage I B Lymphoblastic Lymphoma","enrollment":9350},{"nctId":"NCT04841434","phase":"PHASE1, PHASE2","title":"A Phase I/II Study to Investigate the Use of VORAXAZE™ As Intended Intervention in Patients with CNSL","status":"COMPLETED","sponsor":"Charite University, Berlin, Germany","startDate":"2021-06-01","conditions":"CNS Lymphoma","enrollment":18},{"nctId":"NCT05899751","phase":"","title":"Retrospective Registry Study of Patients With Cancer Treated With High-dose Methotrexate","status":"UNKNOWN","sponsor":"Protherics Medicines Development Limited","startDate":"2022-04-01","conditions":"Acute Kidney Injury, Drug Toxicity","enrollment":1000},{"nctId":"NCT06336395","phase":"PHASE2","title":"Ma-Spore ALL 2020 Study","status":"RECRUITING","sponsor":"National University Hospital, Singapore","startDate":"2020-03-04","conditions":"B Lymphoblastic Leukemia","enrollment":500},{"nctId":"NCT04845035","phase":"PHASE2","title":"Pediatric-Inspired Chemotherapy Plus Tyrosine Kinase Inhibitor in Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia","status":"WITHDRAWN","sponsor":"University of Michigan Rogel Cancer Center","startDate":"2024-01","conditions":"Acute Lymphoblastic Leukemia","enrollment":""},{"nctId":"NCT00005596","phase":"PHASE3","title":"Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia","status":"COMPLETED","sponsor":"Children's Oncology Group","startDate":"2000-04","conditions":"Leukemia","enrollment":1076},{"nctId":"NCT00634504","phase":"PHASE1","title":"Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze","status":"COMPLETED","sponsor":"BTG International Inc.","startDate":"2008-05","conditions":"Osteosarcoma, Leukemia, Lymphoma","enrollment":20},{"nctId":"NCT04179929","phase":"NA","title":"Treatment of Breakpoint Cluster Region-Abelson (BCR-ABL) Negative ALL in Adults","status":"RECRUITING","sponsor":"PETHEMA Foundation","startDate":"2019-11-25","conditions":"Acute Lymphoblastic Leukemia","enrollment":300},{"nctId":"NCT00103285","phase":"PHASE3","title":"Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia","status":"COMPLETED","sponsor":"Children's Oncology Group","startDate":"2005-04-11","conditions":"Acute Lymphoblastic Leukemia, Childhood B Acute Lymphoblastic Leukemia","enrollment":5377},{"nctId":"NCT03797872","phase":"PHASE4","title":"Psoriatic Oligoarthritis Intervention With Symptomatic thErapy","status":"COMPLETED","sponsor":"University of Oxford","startDate":"2019-04-17","conditions":"Psoriatic Arthritis","enrollment":1},{"nctId":"NCT01942174","phase":"PHASE3","title":"VACcination In Methotrexate Treated Rheumatoid Arthritis Patients","status":"COMPLETED","sponsor":"University Hospital, Montpellier","startDate":"2013-09-27","conditions":"Rheumatoid Arthritis","enrollment":276},{"nctId":"NCT03071276","phase":"PHASE2","title":"Selinexor in Combination With Fludarabine and Cytarabine in Patients With Refractory or Relapsed Acute Myeloid Leukemia","status":"TERMINATED","sponsor":"St. Jude Children's Research Hospital","startDate":"2016-01-14","conditions":"Acute Myeloid Leukemia (AML)","enrollment":37},{"nctId":"NCT02212561","phase":"PHASE1","title":"Selinexor With Fludarabine and Cytarabine for Treatment of Refractory or Relapsed Leukemia or Myelodysplastic Syndrome","status":"COMPLETED","sponsor":"St. Jude Children's Research Hospital","startDate":"2014-08","conditions":"Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS)","enrollment":19},{"nctId":"NCT02433184","phase":"PHASE4","title":"Very Early Versus Delayed Etanercept in Patients With RA","status":"COMPLETED","sponsor":"University of Leeds","startDate":"2011-07","conditions":"Rheumatoid Arthritis","enrollment":120},{"nctId":"NCT00004228","phase":"PHASE3","title":"Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma","status":"COMPLETED","sponsor":"Children's Oncology Group","startDate":"2000-06","conditions":"Lymphoma","enrollment":393},{"nctId":"NCT01305655","phase":"PHASE3","title":"Glucarpidase Effect on Severe Delayed HDM-clearance in Children Treated With High-dose Mtx in ALL","status":"COMPLETED","sponsor":"Nordic Society for Pediatric Hematology and Oncology","startDate":"2008-07","conditions":"Acute Lymphoblastic Leukemia (ALL)","enrollment":47},{"nctId":"NCT02150473","phase":"PHASE3","title":"The Effect of Adalimumab Plus Methotrexate (MTX) Versus Placebo Plus MTX on Cartilage in (RA) Patients","status":"TERMINATED","sponsor":"Heinrich-Heine University, Duesseldorf","startDate":"2014-10","conditions":"Rheumatoid Arthritis","enrollment":21},{"nctId":"NCT00028756","phase":"PHASE3","title":"Comparison of Immediate and Delayed Adjuvant Chemotherapy in Treating Patients Who Have Undergone a Radical Cystectomy for Stage III or Stage IV Transitional Cell Carcinoma of the Bladder Urothelium","status":"COMPLETED","sponsor":"European Organisation for Research and Treatment of Cancer - EORTC","startDate":"2001-10","conditions":"Stage III Bladder Cancer, Stage IV Bladder Cancer, Transitional Cell Carcinoma of the Bladder","enrollment":285},{"nctId":"NCT00005945","phase":"PHASE3","title":"Comparison of Different Combination Chemotherapy Regimens in Treating Children With Acute Lymphoblastic Leukemia","status":"COMPLETED","sponsor":"Children's Oncology Group","startDate":"2000-06","conditions":"Leukemia","enrollment":3054},{"nctId":"NCT02339350","phase":"PHASE2","title":"Treatment of Newly Diagnosed High Risk Acute Lymphoblastic Leukemia in Children","status":"UNKNOWN","sponsor":"The Korean Society of Pediatric Hematology Oncology","startDate":"2015-01","conditions":"Acute Lymphoblastic Leukemia, Child","enrollment":110},{"nctId":"NCT00613457","phase":"PHASE3","title":"Combination Chemotherapy Based on Risk of Relapse in Treating Young Patients With Acute Lymphoblastic Leukemia","status":"COMPLETED","sponsor":"Associazione Italiana Ematologia Oncologia Pediatrica","startDate":"2000-09","conditions":"Leukemia","enrollment":2039},{"nctId":"NCT00634322","phase":"PHASE2","title":"High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma","status":"TERMINATED","sponsor":"BTG International Inc.","startDate":"2008-10","conditions":"Osteosarcoma","enrollment":7},{"nctId":"NCT00219791","phase":"PHASE2","title":"Study of Glucarpidase (CPG2) for the Management of Patients With Delayed Methotrexate Clearance","status":"COMPLETED","sponsor":"BTG International Inc.","startDate":"2000-01","conditions":"Neoplasms","enrollment":""},{"nctId":"NCT00176462","phase":"PHASE2","title":"CINJALL: Treatment for Children With Acute Lymphocytic Leukemia","status":"COMPLETED","sponsor":"Rutgers, The State University of New Jersey","startDate":"2001-02","conditions":"Acute Lymphocytic Leukemia","enrollment":60},{"nctId":"NCT00481559","phase":"","title":"Treatment Protocol of Voraxaze for Patients Experiencing or at Risk of Methotrexate Toxicity","status":"APPROVED_FOR_MARKETING","sponsor":"BTG International Inc.","startDate":"","conditions":"Neoplasms","enrollment":""},{"nctId":"NCT00002812","phase":"PHASE3","title":"Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia","status":"COMPLETED","sponsor":"Children's Oncology Group","startDate":"1996-09","conditions":"Leukemia","enrollment":2078},{"nctId":"NCT00424645","phase":"PHASE1, PHASE2","title":"Voraxaze for Delayed Methotrexate Clearance","status":"TERMINATED","sponsor":"M.D. Anderson Cancer Center","startDate":"2007-01","conditions":"Hematologic Malignancy, Solid Tumor","enrollment":3},{"nctId":"NCT01633983","phase":"PHASE2","title":"Methotrexate for Central Serous Chorioretinopathy Treatment Trial","status":"UNKNOWN","sponsor":"Edward Averbukh","startDate":"2012-08","conditions":"Central Serous Chorioretinopathy","enrollment":20},{"nctId":"NCT00222612","phase":"PHASE4","title":"Medical Research Council (MRC) Working Party on Leukaemia in Children UK National Acute Lymphoblastic Leukaemia (ALL) Trial: UKALL 2003","status":"UNKNOWN","sponsor":"University of Oxford","startDate":"2003-10","conditions":"Acute Lymphoblastic Leukemia","enrollment":2100}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":688,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Experimental methotrexate treatment"],"phase":"phase_3","status":"active","brandName":"Methotrexate - Delay","genericName":"Methotrexate - Delay","companyName":"University Hospital, Montpellier","companyId":"university-hospital-montpellier","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Methotrexate is an antimetabolite that inhibits dihydrofolate reductase, disrupting DNA synthesis and cell division. Used for Treatment of certain types of cancer, including leukemia and lymphoma, and autoimmune diseases like rheumatoid arthritis and psoriasis, Prevention of organ transplant rejection.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}