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.

Part of paid clinical trials in New York, New York.

Sponsor
Miltenyi Biomedicine GmbH
Study ID
NCT07717164
Status
Not Yet Recruiting

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Conditions

  • ALL (Acute B-Lymphoblastic Leukemia)
  • AML (Acute Myeloid Leukemia)
  • MDS (Myelodysplastic Syndrome)

Eligibility Criteria

Sex
ALL
Age
1 Year - 66 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Jul 21, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Sep 20, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
51 participants (estimated)

Arms

  • Arm: Arm A: Model-based ATG dosing CD34-selection (PRAISE-IR population)
    CliniMACS CD34 Reagent System
  • Arm: Arm B: Standard ATG dosing CD34-selection (CIBMTR population)
    Intervention: CliniMACS CD34 Reagent System
  • Arm: Arm B*:Standard ATG dosing CD34-selection (BMT CTN 1301 population)
    CliniMACS CD34 Reagent System
  • Arm: Arm C: Control CIBMTR population

Primary Outcome Measure

To Compare overall survival (OS) between patients from PRAISE-IR study (Arm A) to CIBMTR control patients who have received a CD34 selected graft and standard dose ATG (Arm B). [ Time Frame: two years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer centerNew YorkNew York10021-

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Memorial Sloan Kettering Cancer center· New York, NY

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