RightFit
Not yet recruitingPhase not listed

PRAISE-IR Versus CIBMTR Controls

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
1 Year to 66 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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

Study sites (1)

NY