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HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide

Study acronym: ACCESS
StatusActive, Not Recruiting
PhasePhase 2
Started2021-09-30
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 18, 2026 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-03-16
Study Status, Oversight v42
Primary completion date2025-12→2026-08
Completion date2025-12→2026-12
2025-07-25
Recruiting→Active, Not Recruiting Study Status, Oversight, Contacts/Locations v41
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2024-07→2025-12
Completion date2024-07→2025-12
Study sites40→39
2024-05-22
Study Status, Contacts/Locations v40
Study sitesdetails revised at 1 of 40 sites
2024-02-19
Study Status, Contacts/Locations v39
Study sitesdetails revised at 1 of 40 sites
2023-12-05
Study Status, Contacts/Locations v38
Study sitescontacts updated at 1 of 40 sites
Show 37 earlier versions
2023-07-31
Study Status, Contacts/Locations v37
Study sitescontacts updated at 1 of 40 sites
2023-06-08
Study Status, Contacts/Locations v36
Study sites39→40
2023-04-24
Study Status, Contacts/Locations v35
Study sitesdetails revised at 1 of 39 sites
2023-04-19
Study Status, Contacts/Locations v34
Study sites38→39
2023-04-17
Study Status, Contacts/Locations v33
Study sitesdetails revised at 1 of 38 sites
2023-04-06
Study Status, Contacts/Locations v32
Study sites37→38
2023-03-21
Study Status, Contacts/Locations v31
Study sitesdetails revised at 1 of 37 sites
2023-03-02
Study Status, Contacts/Locations v30
Study sites36→37
2023-03-01
Study Status, Contacts/Locations v29
Study sites35→36
2023-02-01
Study Status, Study Design v28
Enrollment target200→300
2023-01-26
Study Status, Contacts/Locations v27
Study sites34→35
2023-01-05
Study Status, Study Design, Eligibility v26
Enrollment target180→200
Eligibility criteria+200 characters
[...] th grade 4 marrow fibrosis Subjects with a prior allogeneic HSC transplant Subjects with an autologous HSC transplant within the past 3 months Females who are breast- [...] gainst a mismatched HLA in the selected donor determined by either: a positive crossmatch test of any titer (by complement-dependent cytotoxicity or flow cytometric testing) or the presence of anti-donor specific HLA antibodyantibodies (DSA) to any mismatched HLA locusallele/antigen at any of the following loci (HLA-A, -B, -C, -DRB1, -DQB1DRB3, DRB4, DRB5, -DQA1, -DPB1DQB1, -DPA1, -DPB1) with meanmedian fluorescence intensity (MFI [...] [...]
2022-12-02
Study Status, Contacts/Locations v25
Study sites33→34
2022-11-14
Study Status, Contacts/Locations v24
Study sites32→33
2022-11-02
Study Status, Contacts/Locations v23
Study sites31→32
2022-10-14
Study Status, Contacts/Locations v22
Study sites30→31
2022-10-05
Study Status, Contacts/Locations v21
Study sites29→30
2022-09-27
Study Status, Contacts/Locations v20
Study sitesdetails revised at 1 of 29 sites
2022-09-19
Study Status, Contacts/Locations v19
Study sites27→29
2022-09-01
Study Status, Contacts/Locations v18
Study sitesdetails revised at 1 of 27 sites
2022-08-11
Study Status, Contacts/Locations v17
Study sites26→27
2022-07-26
Study Status, Contacts/Locations v16
Study sites25→26
2022-07-15
Study Status, Contacts/Locations v15
Study sites24→25
2022-06-29
Study Status, Contacts/Locations v14
Study sites22→24
2022-06-13
Study Status, Contacts/Locations v13
Study sites20→22
2022-04-29
Study Status, Contacts/Locations v12
Study sites19→20
2022-04-15
Study Status, Contacts/Locations v11
Study sites17→19
2022-02-25
Study Status, Eligibility v10
Eligibility criteria+305 characters
[...] ty Index (HCT-CI) < 5 One of the following diagnoses: Acute myelogenousmyeloid leukemia (AML) acute lymphoblastic leukemia (ALL), or other acute leukemia in 1st remission or beyond with ≤ 5% marrow blasts and no circulating blasts or evidence of extra-medullary disease. Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning. Acute lymphoblastic leukemia (ALL) in 1st remission or beyond with ≤ 5% marrow blasts and no circulating blasts or evidence of extra-medullary disease. Documentation of bone marrow assessment will be accepted [...] [...]
2022-02-22
Study Status, Contacts/Locations v9
Study sites16→17
2022-02-15
Study Status, Contacts/Locations v8
Study sites15→16
2022-02-04
Study Status, Contacts/Locations v7
Study sites13→15
2022-01-28
Study Status, Contacts/Locations v6
Study sites11→13
2021-12-02
Study Status, Contacts/Locations v5
Study sites4→11
2021-10-19
Study Status, Contacts/Locations v4
Study sites3→4
2021-10-01
Study Status, Contacts/Locations v3
Start dateestimated 2021-09→confirmed 2021-09-30
Study sites2→3
2021-09-29
Study Status, Contacts/Locations v2
Study sites1→2
2021-09-09
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2021-08→2021-09
Study sites0→1
2021-05-26
Original filing
This is a prospective, multi-center, Phase II study of hematopoietic cell transplantation (HCT) using human leukocyte antigen (HLA)-mismatched unrelated donors (MMUD) for peripheral blood stem cell transplant in adults and bone marrow stem cell transplant in children. Post-transplant cyclophosphamide (PTCy), tacrolimus and mycophenolate mofetil (MMF) will be used for for graft versus host disease (GVHD) prophylaxis. This trial will study how well this treatment works in patients with hematologic malignancies.
Trial Details
NCT Number NCT04904588
Lead Sponsor Center for International Blood and Marrow Transplant Research
Collaborators: National Marrow Donor Program
Conditions Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Mixed Phenotype Acute Leukemia, Acute Leukemia, Myelodysplastic Syndromes, Chronic Myelogenous Leukemia, Chronic Lymphocytic Leukemia, Lymphoma
Enrollment 300 participants
Start Date 2021-09-30
Primary Completion 2026-08 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-18