← Back to all trials
Not Yet Recruiting
NCT07717164
The Rationale to Conduct This RWE Study is to Provide Data to Support the Safety of CD34 Selected Grafts Versus T Replete PBSC Transplants to Address Concerns About Increased TRM in CD34 Selected Graft Recipients.
Conditions: ALL (Acute B-Lymphoblastic Leukemia), AML (Acute Myeloid Leukemia), MDS (Myelodysplastic Syndrome)
Sex: All
Ages: 1 Year – 66 Years
Healthy volunteers: No
Enrollment: 51
Sponsor: Miltenyi Biomedicine GmbH
Location: Memorial Sloan Kettering Cancer center New York New York
Summary
The rationale to conduct this RWE study is to provide data to support the safety of CD34 selected grafts versus T replete PBSC transplants to address concerns about increased TRM in CD34 selected graft recipients.
Eligibility Criteria
Inclusion Criteria:
Arm A: Model-based ATG dosing CD34-selection (PRAISE-IR population)
* Patients who participated in the PRAISE-IR single center phase II study
* Patient age at transplant: ≥ 1 year and \< 66 years
* HLA 8/8 MRD or MUD
* Conditioning intensity: myeloablative
* Conditioning regimens: Model-based ATG with TBI/Thiotepa/Cyclophospamide (TBI/Thio/Cy) or Busulfan/Melphalan/Fludarabine (Bu/Mel/Flu).
* Morphologic complete remission at the time of alloHCT Arm B: Standard ATG dosing CD34-selection (CIBMTR population)
* First AlloHCT in the US between 2021-2023
* Patient age at transplant: ≥ 1 year and \< 66 years
* Disease: Patients with AML, MDS, and ALL
* HLA 8/8 MRD or MUD
* Peripheral blood stem cell allograft
* Conditioning intensity: myeloablative conditioning
* Conditioning regimens: standard dose ATG (2.5 mg/kg/day given on Day -4 and Day -3)
* GVHD prophylaxis: ex vivo CD34 selection
* Morphologic complete remission at the time of alloHCT Arm B\*:Standard ATG dosing CD34-selection (BMT CTN 1301 population)
* Patients in BMT CTN 1301, who received the CD34-selected graft
* Patient age at transplant: ≥ 1 year and \< 66 years
* Disease:Patients with AML, MDS, and ALL
* HLA 8/8 MRD or MUD
* Peripheral blood stem cell allograft
* Conditioning intensity: myeloablative conditioning
* Conditoning regmens: TBI/Thiotepa/Cyclophospamide (TBI/Thio/Cy) or Busulfan/Melphalan/Fludarabine (Bu/Mel/Flu) and standard dose ATG (2.5 mg/kg/day given on Day -4 and Day -3)
* GVHD prophylaxis: ex vivo CD34 selection
* Morphologic complete remission at the time of alloHCT Arm C: Control CIBMTR population
* First AlloHCT in the US between 2021-2023
* Patient age at transplant: ≥ 1 year and \< 66 years
* Disease:Patients with AML, MDS, and ALL
* HLA 8/8 MRD or MUD
* Peripheral blood stem cell
* Conditioning intensity: myeloablative conditioning
* Conditioning regimens: Busulfan/Cyclophosphamide (Bu/Cy), Busulfan/Fludaranbine (Bu/Flu), Cyclophosphamide/TBI (Cy/TBI), TBI/Etopsoside
* GVHD prophyalxis: / CNI or PTCy-based
* CNI-based: CNI (tacrolimus or ciclosporin) plus MTX
* PTCy-based: Cyclophosphamide on day +3 and +4 (50 mg/kg/d) combined with CNI and mycophenolate mofetil (MMF)
Exclusion Criteria:
Patients will be entered into this trial only if they meet none of the following criteria:
Arm A: Model-based ATG dosing CD34-selection (PRAISE-IR population)
* HLA \
Source: ClinicalTrials.gov (NCT07717164). StuddyBuddy aggregates publicly available trial information.