PRAISE-IR Versus CIBMTR Controls (NCT07717164) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
PRAISE-IR Versus CIBMTR Controls
United States51 participantsStarted 2026-07-31
Plain-language 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.
Who can participate
Age range
1 Year – 66 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing outcomes from a group called PRAISE-IR against historical data from a registry called CIBMTR — can you explain what that means for my care, and whether being evaluated against past patients' records rather than a live control group changes how reliable the results will be?
2The trial is listed as 'not yet recruiting' — how soon do you expect it to open, and does that timing affect whether I should consider waiting for it versus starting standard treatment now?
3The trial covers three different diagnoses — ALL, AML, and MDS — so can you help me understand whether the findings from patients with a different blood cancer than mine would still be meaningful for my specific situation?
4The primary goal is to show that Arm A is actually superior to a CD34-selected graft plus standard-dose ATG approach — can you walk me through what those two approaches involve and what risks or trade-offs each one carries for someone in my position?
5Since this study doesn't have a listed phase, what does that tell us about how much safety and effectiveness data already exists for the PRAISE-IR approach, and how does that compare to what's known about the standard transplant method being used as the control?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.