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Starting soon Observational

PRAISE-IR Versus CIBMTR Controls

NCT07717164 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2026-07-31
Last updated
2026-07-28

Condition(s) studied

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

Study 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

Sex
ALL
Min age
1 Year
Max age
66 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Comparison of OS between PRAISE-IR study participants (Arm A) with CIBMTR control participants who have received a CD34 selected graft and standard dose ATG (Arm B) with the goal of demonstrating superiority of Arm A. — two years
    Comparison of overall survival (OS) between PRAISE-IR study participants (Arm A) with CIBMTR control participants who have received a CD34 selected graft and standard dose ATG (Arm B). Note: If the number of participants meeting the criteria for Arm B is insufficient for 1:1 matching, Arm A could be compared with the CD34 selection group from the BMT CTN1301 study (Arm B\*). Comparison of OS between PRAISE-IR study participants (Arm A) with CIBMTR control patients who have received standard of care (SoC) allogeneic hematopoietic stem cell transplantation (alloHCT) without CD34 selection with post transplantation cyclophosphamide (PTCy) and Calcineurin inhibitor (CNI)/Methotrexate (MTX) for GVHD prophylaxis (Arm C).

Trial sites (1)

FacilityCityRegionStatus
Memorial Sloan Kettering Cancer center New York New York
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07717164 on ClinicalTrials.gov ↗ ← All trials in the USA