{"id":"fludarabine-okt3-treosulfan-thiotepa","safety":{"commonSideEffects":[{"rate":null,"effect":"Myelosuppression / neutropenia"},{"rate":null,"effect":"Infection"},{"rate":null,"effect":"Mucositis"},{"rate":null,"effect":"Nausea and vomiting"},{"rate":null,"effect":"Hepatotoxicity"},{"rate":null,"effect":"Graft-versus-host disease"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Fludarabine is a purine analog that inhibits DNA synthesis in lymphocytes; OKT3 is a monoclonal antibody targeting CD3 on T cells for immune depletion; Treosulfan and Thiotepa are alkylating agents that cause DNA crosslinking and cell death. Together, this regimen provides myeloablation and immunosuppression to prepare patients for stem cell transplantation and reduce graft rejection and leukemic relapse.","oneSentence":"This is a multi-drug conditioning regimen combining purine analog, T-cell depleting monoclonal antibody, and alkylating agents to suppress the immune system and ablate bone marrow prior to hematopoietic stem cell transplantation.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:12:55.141Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Conditioning regimen prior to hematopoietic stem cell transplantation in pediatric leukemia and lymphoma"}]},"trialDetails":[{"nctId":"NCT01423747","phase":"PHASE3","title":"Allogeneic Stem Cell Transplantation in Children and Adolescents With Acute Lymphoblastic Leukaemia","status":"UNKNOWN","sponsor":"St. Anna Kinderkrebsforschung","startDate":"2003-07","conditions":"Lymphoblastic Leukemia, Acute, Childhood;","enrollment":400},{"nctId":"NCT01423500","phase":"PHASE3","title":"ALL-SCT BFM International- HSCT in Children and Adolescents With ALL","status":"UNKNOWN","sponsor":"St. Anna Kinderkrebsforschung","startDate":"2007-01","conditions":"Lymphoblastic Leukemia, Acute, Childhood;","enrollment":405}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["ATG:Antithymoglobuline","ATG: Antithymoglobuline"],"phase":"phase_3","status":"active","brandName":"Fludarabine, OKT3, Treosulfan, Thiotepa","genericName":"Fludarabine, OKT3, Treosulfan, Thiotepa","companyName":"St. Anna Kinderkrebsforschung","companyId":"st-anna-kinderkrebsforschung","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This is a multi-drug conditioning regimen combining purine analog, T-cell depleting monoclonal antibody, and alkylating agents to suppress the immune system and ablate bone marrow prior to hematopoietic stem cell transplantation. Used for Conditioning regimen prior to hematopoietic stem cell transplantation in pediatric leukemia and lymphoma.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}