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NCT Number: NCT07717164

PRAISE-IR Versus CIBMTR Controls

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.

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Key information

Conditions

ALL (Acute B-Lymphoblastic Leukemia) AML (Acute Myeloid Leukemia) Anemia Anemia, Refractory Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute MDS (Myelodysplastic Syndrome) Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type

Age range

1 year–66 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer center

New York, 10021, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: 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).

Secondary outcomes

  1. Acute GVHD, grades II-IV

    Time frame: two years

    Acute Graft-versus-Host Disease (GVHD), grades II-IV

  2. Chronic GVHD

    Time frame: two years

    Chronic Graft-versus-Host Disease (GVHD)

  3. Hematologic recovery (time to neutrophil engraftment and time to platelet engraftment)

    Time frame: two years

    Hematologic recovery (time to neutrophil engraftment and time to platelet engraftment)

  4. Rate of primary graft failure

    Time frame: two years

    Rate of primary graft failure

  5. Non-relapse mortality

    Time frame: two years

    Non-relapse mortality

  6. Relapse

    Time frame: two years

    Relapse

  7. Relapse-free survival

    Time frame: two years

    Relapse-free survival

Study contacts

Contact information is provided by the study sponsor or research team.

Michaela Malchow

CONTACT

[email protected]

+49 15117151746

Sponsors and collaborators

Lead sponsor

Miltenyi Biomedicine GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 21, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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