ALL (Acute B-Lymphoblastic Leukemia)NCT07717164
PRAISE-IR Versus CIBMTR Controls
An observational study of ALL (Acute B-Lymphoblastic Leukemia) and AML (Acute Myeloid Leukemia), run by Miltenyi Biomedicine GmbH at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 66 years
- Conditions the study is for
- ALL (Acute B-Lymphoblastic Leukemia), AML (Acute Myeloid Leukemia), MDS (Myelodysplastic Syndrome)
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2026to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 66 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Disease: Patients with AML, MDS, and ALL
Who may be able to join
- 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).
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Memorial Sloan Kettering Cancer center
New York, New York, 10021
About this study
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
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.
Read the 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
- Conditions
- ALL (Acute B-Lymphoblastic Leukemia), AML (Acute Myeloid Leukemia), MDS (Myelodysplastic Syndrome)
- Medical subject headings
- Leukemia, Myeloid, Acute, Anemia, Refractory, with Excess of Blasts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Model-based ATG dosing CD34-selection (PRAISE-IR population) | CliniMACS CD34 Reagent System | |
| Arm B: Standard ATG dosing CD34-selection (CIBMTR population) | Intervention: CliniMACS CD34 Reagent System | |
| Arm B*:Standard ATG dosing CD34-selection (BMT CTN 1301 population) | CliniMACS CD34 Reagent System | |
| Arm C: Control CIBMTR population | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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).
Measured: two years
Secondary outcomes (7)
Acute GVHD, grades II-IV
Acute Graft-versus-Host Disease (GVHD), grades II-IV
Measured: two years
Chronic GVHD
Chronic Graft-versus-Host Disease (GVHD)
Measured: two years
Hematologic recovery (time to neutrophil engraftment and time to platelet engraftment)
Hematologic recovery (time to neutrophil engraftment and time to platelet engraftment)
Measured: two years
Rate of primary graft failure
Rate of primary graft failure
Measured: two years
Non-relapse mortality
Non-relapse mortality
Measured: two years
Relapse
Relapse
Measured: two years
Relapse-free survival
Relapse-free survival
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start31 Jul 2026 (estimated)
- Primary completion20 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALL (Acute B-Lymphoblastic Leukemia)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miltenyi Biomedicine GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717164
- Sponsor's protocol ID
- PROJXXXX
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07717164
- Acronym / sponsor ID
- PROJXXXX
- Conditions
- ALL (Acute B-Lymphoblastic Leukemia), AML (Acute Myeloid Leukemia), MDS (Myelodysplastic Syndrome)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Miltenyi Biomedicine GmbHIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A: Model-based ATG dosing CD34-selection (PRAISE-IR population) | – | –CliniMACS CD34 Reagent System |
| Arm B: Standard ATG dosing CD34-selection (CIBMTR population) | – | –Intervention: CliniMACS CD34 Reagent System |
| Arm B*:Standard ATG dosing CD34-selection (BMT CTN 1301 population) | – | –CliniMACS CD34 Reagent System |
| Arm C: Control CIBMTR population | – | – |
Who may qualify
- Ages
- 1 year to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Disease: Patients with AML, MDS, and ALL
Key inclusion criteria (35 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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).
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ALL (Acute B-Lymphoblastic Leukemia) and AML (Acute Myeloid Leukemia), run by Miltenyi Biomedicine GmbH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 35 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michaela Malchow (+49 15117151746, Michaela.Malchow@miltenyi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.