Clinical trial · Observational
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
NCT07717164CI-TRIAL-00119599not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALL (Acute B-Lymphoblastic Leukemia) | Acute Lymphoblastic Leukemia | ALIAS | 0.85 |
| AML (Acute Myeloid Leukemia) | Acute Myeloid Leukemia | ALIAS | 0.90 |
| MDS (Myelodysplastic Syndrome) | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (4)
- label
- Arm A: Model-based ATG dosing CD34-selection (PRAISE-IR population)
- description
- CliniMACS CD34 Reagent System
- label
- Arm B: Standard ATG dosing CD34-selection (CIBMTR population)
- description
- Intervention: CliniMACS CD34 Reagent System
- label
- Arm B*:Standard ATG dosing CD34-selection (BMT CTN 1301 population)
- description
- CliniMACS CD34 Reagent System
- label
- Arm C: Control CIBMTR population
Primary outcomes (1)
- measure
- 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.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 66 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.