PRAISE-IR Versus CIBMTR Controls
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: ALL (Acute B-Lymphoblastic Leukemia), AML (Acute Myeloid Leukemia), MDS (Myelodysplastic Syndrome). Basic parameters: 1 year — 66 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Detailed description
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
Primary outcome 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. [Time frame: two years]
Secondary outcome measures (7)
- Acute GVHD, grades II-IV [Time frame: two years]
- Chronic GVHD [Time frame: two years]
- Hematologic recovery (time to neutrophil engraftment and time to platelet engraftment) [Time frame: two years]
- Rate of primary graft failure [Time frame: two years]
- Non-relapse mortality [Time frame: two years]
- Relapse [Time frame: two years]
- Relapse-free survival [Time frame: two years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Memorial Sloan Kettering Cancer center — New York
Identifiers
NCT: NCT07717164 · PROJXXXX