MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT07493538
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Treosulfan — DRUG
    12 g/m2 administered intravenously over 2 hours on days -4, -3, and -2.
  • Fludarabine — DRUG
    Fludarabine will be administered intravenously over 1 hour, every 24 hours on days -6 to -2. The daily dose of fludarabine will be determined by model-based dosing utilizing Bayesian methodology .
  • Total Body Irradiation — RADIATION
    TBI 200 cGy will be administered as a single treatment on day -1 per current institutional guidelines.
  • Tacrolimus — DRUG
    Tacrolimus may be initiated on day +5 either PO or IV gtt , with a goal trough level of 5-10mg/mL and avoiding higher levels for the first two weeks post-transplant, as recent evidence demonstrated increased adverse events for levels over 10 mg/mL.
  • Mycophenolate Mofetil — DRUG
    All patients begin mycophenolate mofetil (MMF) day +5 through day +35 if no acute GVHD or 7 days after engraftment, whichever is later.
  • Cyclophosphamid — DRUG
    Cyclophosphamide 40 mg/kg will be given as an IV infusion over 1-2 hours (depending on volume) on Days +3 post-transplant (between 60 and 72 hours after stem cell infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide).
  • Stem Cell Infusion — BIOLOGICAL
    Given on day 0.

Study Details

This is a Phase II study following subjects proceeding with Treosulfan (36g/m2) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion, with post-transplant cyclophosphamide (PTCy) at 40mg/kg, tacrolimus and MMF for GVHD prophylaxis.

Key Dates

Start date
Apr 10, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2030
Completion
Mar 31, 2035

Study Design

Enrollment
132 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treo/Flu with PTCy
    Subjects treated with Treosulfan and Fludarabine preparative regimen with TBI for AML and MDS patients followed by a related or unrelated donor stem cell infusion utilizing PTCy, tacrolimus and MMF as GVHD prophylaxis.

Primary Outcome Measure

Overall Survival [ Time Frame: Day 100 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Masonic Cancer Center at University of MinnesotaMinneapolisMinnesota55455-

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By research site
Masonic Cancer Center at University of Minnesota· Minneapolis, MN

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