{"preliminary_commentary":{"by_channel":{"bluesky_thread":2,"x_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":"ACCESS","nct_id":"NCT04904588","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=access-nct04904588. 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":"ACCESS","arms":[{"description":"Patients receive:\n\n* Busulfan (≥ 9 mg/kg total dose) IV or PO on days -6 to -3\n* 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.","label":"Regimen A (MAC: busulfan and fludarabine, PBSC HCT)","type":"EXPERIMENTAL"},{"description":"Patients receive:\n\n* Fludarabine (90 mg/m2 total dose) IV on days -7 to -5\n* Total body irradiation (TBI) (1200 cGy total dose) on days -4 to -1\n\nPatients receive a PBSC graft infusion from a mismatched unrelated donor on Day 0.","label":"Regimen B (MAC: Fludarabine and TBI; PBSC HCT)","type":"EXPERIMENTAL"},{"description":"Patients receive:\n\n* Fludarabine (120-180 mg/m2 total dose) IV on days -6 to -2\n* 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 PBSC graft infusion from a mismatched unrelated donor on Day 0.","label":"Regimen C (RIC: Fludarabine and Busulfan; PBSC HCT)","type":"EXPERIMENTAL"},{"description":"Patients receive:\n\n* Fludarabine (120-180 mg/m2 total dose) IV on days -7 to -3\n* Melphalan (100-140 mg/m2) IV on day -1\n\nPatients receive a PBSC graft infusion from a mismatched unrelated donor on Day 0.","label":"Regimen D (RIC: Fludarabine and Melphalan; PBSC HCT)","type":"EXPERIMENTAL"},{"description":"Patients receive:\n\n* Fludarabine (150 mg/m2 total dose) IV on days -6 to -2\n* Cyclophosphamide (29-50 mg/kg) IV on days -6 and -5\n* TBI (200 cGy) on day -1\n\nPatients receive a PBSC graft infusion from a mismatched unrelated donor on Day 0.","label":"Regimen E (NMA: Fludarabine, Cyclophosphamide, TBI; PBSC HCT)","type":"EXPERIMENTAL"},{"description":"Patients receive:\n\n* Busulfan (dosed by age and weight per institutional standards to target goal pharmacokinetic (PK) in range noted in protocol.) on days -6 to -3\n* Cyclophosphamide (100 mg/kg total dose) IV on days -2 and -1\n\nPatients receive a bone marrow (BM) graft infusion from a mismatched unrelated donor on Day 0.","label":"Regimen F (MAC: Busulfan and Cyclophosphamide; BM HCT)","type":"EXPERIMENTAL"},{"description":"Patients receive:\n\n* Cyclophosphamide (100 mg/kg total dose) IV on days -5 and -4\n* TBI (1200 cGy total dose) on days -3, -2 and -1\n\nPatients receive a BM graft infusion from a mismatched unrelated donor on Day 0.","label":"Regimen G (MAC: Cyclophosphamide and TBI; BM HCT)","type":"EXPERIMENTAL"}],"collaborators":["National Marrow Donor Program"],"completion_date":{"date":"2026-12","type":"ESTIMATED"},"conditions":["Acute Lymphoblastic Leukemia","Acute Myelogenous Leukemia","Mixed Phenotype Acute Leukemia","Acute Leukemia","Myelodysplastic Syndromes","Chronic Myelogenous Leukemia","Chronic Lymphocytic Leukemia","Lymphoma"],"enrollment":{"count":300,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Busulfan","otherNames":["Busulfex®"],"type":"DRUG"},{"name":"Busulfan","otherNames":["Busulfex®"],"type":"DRUG"},{"name":"Fludarabine","otherNames":["Fludara®"],"type":"DRUG"},{"name":"Total-body irradiation","otherNames":["TBI"],"type":"RADIATION"},{"name":"Cyclophosphamide","otherNames":["Cytoxan®"],"type":"DRUG"},{"name":"Melphalan","otherNames":[],"type":"DRUG"},{"name":"PBSC Hematopoietic Stem Cell Transplantation (HSCT)","otherNames":["PBSC HSCT","PBSC HCT","PBSC Transplantation"],"type":"PROCEDURE"},{"name":"Bone Marrow Hematopoietic Stem Cell Transplantation","otherNames":["BM HSCT","BM HCT","Bone Marrow Transplantation"],"type":"PROCEDURE"},{"name":"Post-transplant Cyclophosphamide","otherNames":["Cytoxan®"],"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":[],"type":"OTHER"}],"last_update":"2026-03-18","lead_sponsor":"Center for International Blood and Marrow Transplant Research","official_title":"A Multi-Center, Phase II Trial of HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide for Patients With Hematologic Malignancies","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2026-08","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Overall Survival","timeFrame":"1 year post HCT"}],"references":[{"citation":"Jimenez Jimenez AM, Stanek J, Logan BR, Leckrone E, Stefanski HE, Auletta JJ, Spellman SR, Malmberg C, Askar M, Cusatis RN, Shaffer BC, Modi D, Khimani F, Gooptu M, Hamadani M, Maiers M, Bo-Subait S, Bolanos-Meade J, Rao U, Milner J, Abboud R, Jamieson KJ, Carrum G, Dholaria B, Hogan WJ, Reshef R, Kosuri S, Cook RJ, Ballen K, Loren AW, Larkin K, Arai S, Qayed M, Choi SW, Broglie L, Shaw BE, Devine SM, Al Malki MM. Outcomes after 7/8 and <7/8 mismatched unrelated donor PBSC transplantation with PTCy: results from the ACCESS trial. Blood Adv. 2026 Aug 19:bloodadvances.2026021081. doi: 10.1182/bloodadvances.2026021081. Online ahead of print.","pmid":"42616616","type":"DERIVED"},{"citation":"Auletta JJ, Stanek J, Bo-Subait S, Al Malki MM, Cook R, Gooptu M, Shaffer B, Jimenez AJ, Modi D, Hill JA, Huppler AR, Kou J, Cusatis R, Broglie L, Shaw BE, Stefanski H, Spellman SR, Devine SM. Infection burden in mismatched unrelated donor hematopoietic cell transplantation: results from the ACCESS trial. Blood Adv. 2026 Oct 13;10(19):6551-6563. doi: 10.1182/bloodadvances.2026020882.","pmid":"42448319","type":"DERIVED"},{"citation":"Al Malki MM, Bo-Subait S, Logan B, Olson J, Kou J, Smith S, Leckrone E, Wu J, Stefanski HE, Auletta JJ, Spellman SR, Malmberg C, Askar M, Cusatis R, Shaffer BC, Modi D, Khimani F, Gooptu M, Hamadani M, Madbouly A, Maiers M, Fingerson S, Cook R, Ballen K, Loren A, Larkin K, Arai S, Qayed M, Choi SW, Broglie L, Shaw BE, Devine SM, Jimenez Jimenez AM. Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis After Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation. J Clin Oncol. 2025 Sep;43(25):2772-2781. doi: 10.1200/JCO-25-00856. Epub 2025 Jun 16.","pmid":"40523209","type":"DERIVED"}],"start_date":{"date":"2021-09-30","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide","url":"https://clinicaltrials.gov/study/NCT04904588"},"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/access-nct04904588"}