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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.

Sponsor: Miltenyi Biomedicine GmbH

View on ClinicalTrials.gov

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.

Official title: Comparison of the PRAISE -IR ("Phase 2 Study of Personalized r-ATG Dosing to Improve Survival Through Enhanced Immune Reconstitution in Pediatric and Adult Patients Undergoing Ex-vivo CD34-Selected Allogeneic-HCT", NCT04872595) Study Population With CIBMTR Controls

Key Details

Gender

All

Age Range

1 Year - 66 Years

Study Type

OBSERVATIONAL

Enrollment

Start Date

2026-07-31

Completion Date

2026-09-30

Last Updated

2026-07-21

Healthy Volunteers

Conditions

ALL (Acute B-Lymphoblastic Leukemia)AML (Acute Myeloid Leukemia)MDS (Myelodysplastic Syndrome)

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 \<8/8 MRD or MUD Arm B: Standard ATG dosing CD34-selection (CIBMTR population) * Patients who participated in the PRAISE-IR study * Patients who did not sign consent for research * Patient transplanted at a center that does not meet CIBMTR data quality standards * Use of CNI-(Tac/MTX) or PTCy-based GVHD prophylaxis Arm B\*:Standard ATG dosing CD34-selection (BMT CTN 1301 population) * Patients who did not sign consent for research * Patient transplanted at a center that does not meet CIBMTR data quality standards * Use of CNI- or PTCy-based GVHD prophylaxis Arm C: Control CIBMTR population * Patients who did not sign consent for research * Patient transplanted at a center that does not meet CIBMTR data quality standards * Use of ATG and/or alemtuzumab * Patients who received PTCy with sirolimus (and not a CNI) * Use of ex vivo CD34 selection

Locations (1)

Memorial Sloan Kettering Cancer center

New York, New York, United States