{"preliminary_commentary":{"by_channel":{"x_thread":2,"bluesky_thread":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"name":"OPTIMIZE","nct_id":"NCT06001385","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=optimize-nct06001385. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"OPTIMIZE","arms":[{"description":"Patients Receive:\n\nPatients receive:\n\nBusulfan (≥ 9 mg/kg total dose) IV or PO on days -6 to -3 Fludarabine (150 mg/m2 total dose) IV on days -6 to -2\n\nPatients receive a peripheral blood stem cell (PBSC) graft infusion from a mismatched unrelated donor on Day 0.\n\nPatients receive a reduced dose of cyclophosphamide (25mg/kg per dose) on Day 3 and Day 4 post-transplant.\n\nFirst 20 patients with a 4-6/8 mismatched unrelated donor will receive an alternate dose of post-transplant cyclophosphamide of 37.5 mg/kg on Days 3 and Day 4 post-transplant.","label":"Regimen A (MAC: Busulfan and Fludarabine, PBSC HCT; Reduce Dose PTCy","type":"EXPERIMENTAL"},{"description":"Patients receive:\n\nFludarabine (90 mg/m2 total dose) IV on days -7 to -5 Total body irradiation (TBI) (1200 cGy total dose) on days -4 to -1\n\nPatients receive a peripheral blood stem cell (PBSC) graft infusion from a mismatched unrelated donor on Day 0.\n\nPatients receive a reduced dose of cyclophosphamide (25mg/kg per dose) on Day 3 and Day 4 post-transplant.\n\nFirst 20 patients with a 4-6/8 mismatched unrelated donor will receive an alternate dose of post-transplant cyclophosphamide of 37.5 mg/kg on Days 3 and Day 4 post-transplant.","label":"Regimen B (MAC: Fludarabine and TBI, PBSC HCT; Reduce Dose PTCy","type":"EXPERIMENTAL"},{"description":"Patients receive:\n\nFludarabine (150-180 mg/m2 total dose) IV on days -6 to -2 Busulfan (less than or equal to 8 mg/kg PO or 6.4 mg/kg IV) on days -5 and -4\n\nPatients receive a peripheral blood stem cell (PBSC) graft infusion from a mismatched unrelated donor on Day 0.\n\nPatients receive a reduced dose of cyclophosphamide (25mg/kg per dose) on Day 3 and Day 4 post-transplant.\n\nFirst 20 patients with a 4-6/8 mismatched unrelated donor will receive an alternate dose of post-transplant cyclophosphamide of 37.5 mg/kg on Days 3 and Day 4 post-transplant.","label":"Regimen C (RIC: Fludarabine and Busulfan; PBSCT HCT; Reduced Dose PTCy","type":"EXPERIMENTAL"},{"description":"Patients receive:\n\nFludarabine (125-150 mg/m2 total dose) IV on days -7 to -3 Melphalan (100-140 mg/m2) IV on day -1\n\nPatients receive a PBSC graft infusion from a mismatched unrelated donor on Day 0.\n\nPatients receive a reduced dose of cyclophosphamide (25mg/kg per dose) on Day 3 and Day 4 post-transplant.\n\nFirst 20 patients with a 4-6/8 mismatched unrelated donor will receive an alternate dose of post-transplant cyclophosphamide of 37.5 mg/kg on Days 3 and Day 4 post-transplant.","label":"Regimen D (RIC: Fludarabine and Melphalan; PBSCT HCT; Reduced Dose PTCy","type":"EXPERIMENTAL"},{"description":"Patients receive:\n\nFludarabine (150mg/m2 total dose) IV on days -6 to -2 Cyclophosphamide (29-50mg/kg) IV on days -6 and -5 TBI (200cGy) on day -1\n\nPatients receive a PBSC graft infusion from a mismatched unrelated donor on Day 0.\n\nPatients receive a reduced dose of cyclophosphamide (25mg/kg per dose) on Day 3 and Day 4 post-transplant.\n\nFirst 20 patients with a 4-6/8 mismatched unrelated donor will receive an alternate dose of post-transplant cyclophosphamide of 37.5 mg/kg on Days 3 and Day 4 post-transplant.","label":"Regimen E (NMA: Fludarabine, Cyclophosphamide, and TBI; PBSCT HCT; Reduced Dose PTCy","type":"EXPERIMENTAL"}],"collaborators":["National Marrow Donor Program"],"completion_date":{"date":"2026-12-30","type":"ESTIMATED"},"conditions":["Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Acute Leukemia","Myelodysplastic Syndromes","Chronic Myeloid Leukemia","Chronic Lymphocytic Leukemia","Myeloproliferative Neoplasm","Lymphoma","Chronic Myelomonocytic Leukemia","Pro-Lymphocytic Leukemia","Myelofibrosis"],"enrollment":{"count":313,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Busulfan","otherNames":["Busulfex®"],"type":"DRUG"},{"name":"Fludarabine","otherNames":["Fludara®"],"type":"DRUG"},{"name":"PBSC Hematopoietic Stem Cell Transplantation (HSCT)","otherNames":["PBSC HSCT","PBSC HCT","PBSC Transplantation","PBSCT"],"type":"PROCEDURE"},{"name":"Post-Transplant Cyclophosphamide","otherNames":["Cytoxan®","PTCy"],"type":"DRUG"},{"name":"Mesna","otherNames":["Mesnex®"],"type":"DRUG"},{"name":"Tacrolimus","otherNames":[],"type":"DRUG"},{"name":"Mycophenolate Mofetil","otherNames":["MMF","Cellcept®"],"type":"DRUG"},{"name":"Patient Reported Outcomes","otherNames":["PRO"],"type":"OTHER"},{"name":"Melphalan","otherNames":[],"type":"DRUG"},{"name":"Total-body irradiation","otherNames":["TBI"],"type":"RADIATION"},{"name":"Cyclophosphamide","otherNames":["Cytoxan®"],"type":"DRUG"}],"last_update":"2026-08-17","lead_sponsor":"Center for International Blood and Marrow Transplant Research","official_title":"A Phase II Study of Reduced Dose Post Transplantation Cyclophosphamide as GvHD Prophylaxis in Adult Patients With Hematologic Malignancies Receiving HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2026-12-24","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Infection Free Survival","timeFrame":"100 days post-HCT"}],"references":[],"start_date":{"date":"2023-12-08","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation With Reduced Dose Post Transplantation Cyclophosphamide GvHD Prophylaxis","url":"https://clinicaltrials.gov/study/NCT06001385"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/optimize-nct06001385"}