PRAISE-IR Versus CIBMTR Controls

NCT07717164 | Not Yet Recruiting

• 1 other identifier: PROJXXXX
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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.

  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).

  two years

Secondary Outcomes (7)

• Acute GVHD, grades II-IV

  two years

• Chronic GVHD

  two years

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

  two years

• Rate of primary graft failure

  two years

• Non-relapse mortality

  two years

Study Arms (4)

Arm A: Model-based ATG dosing CD34-selection (PRAISE-IR population)

CliniMACS CD34 Reagent System

Arm B: Standard ATG dosing CD34-selection (CIBMTR population)

Intervention: CliniMACS CD34 Reagent System

Arm B*:Standard ATG dosing CD34-selection (BMT CTN 1301 population)

CliniMACS CD34 Reagent System

Arm C: Control CIBMTR population

Eligibility Criteria

• Age: 1 Year - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Disease: Patients with AML, MDS, and ALL

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Miltenyi Biomedicine GmbH: lead

Study Sites (1)

Memorial Sloan Kettering Cancer center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Anemia, Refractory, with Excess of Blasts

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Refractory; Anemia; Myelodysplastic Syndromes; Bone Marrow Diseases

Central Study Contacts

Michaela Malchow

CONTACT

+49 15117151746; Michaela.Malchow@miltenyi.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

US (1)