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Observational Study Comparing PRAISE-IR Participants with CIBMTR Controls for Blood Cancers

This observational study is comparing outcomes for patients who previously participated in the PRAISE-IR study with a group of control patients from the CIBMTR (Center for International Blood and Marrow Transplant Research) registry. The PRAISE-IR study involved a specific type of stem cell transplant using CD34-selected grafts and personalized dosing of ATG (anti-thymocyte globulin), which affects the RAF mechanism. This study aims to see if the PRAISE-IR approach leads to better overall survival compared to standard CD34-selected grafts with standard ATG. You might be able to join if you were in the original PRAISE-IR study, are between 1 and 66 years old, and had a specific type of stem cell transplant for acute B-lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), or myelodysplastic syndrome (MDS). The study is looking to enroll 51 participants, but its current recruitment status is unclear.

Study design
This is an observational study comparing two groups of patients. It aims to enroll 51 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is to compare overall survival at two years.

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NCT07717164

PRAISE-IR Versus CIBMTR Controls

Not Yet Recruiting
Not specifiedAges 1–66Observational
Miltenyi Biomedicine GmbH
~51 participants
Updated 2026-07-28 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over two years

Conditions

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

Explore related trials

Acute B-Lymphoblastic LeukemiaAcute Myeloid LeukemiaMyelodysplastic Syndrome

Where it's being run

1 sites across 1 states
New York1

Who to contact

Michaela Malchow
[email protected]
+49 15117151746
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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).