NCT07493538

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 2 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• AML
• MDS
• Acute Leukemia
• Acute Myeloid Leukemia
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Treosulfan	12 g/m2 administered intravenously over 2 hours on days -4, -3, and -2.
DRUG	Fludarabine	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 .
RADIATION	Total Body Irradiation	TBI 200 cGy will be administered as a single treatment on day -1 per current institutional guidelines.
DRUG	Tacrolimus	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.
DRUG	Mycophenolate Mofetil	All patients begin mycophenolate mofetil (MMF) day +5 through day +35 if no acute GVHD or 7 days after engraftment, whichever is later.
DRUG	Cyclophosphamid	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).
BIOLOGICAL	Stem Cell Infusion	Given on day 0.

Timeline

• Start date: 2026-04-10
• Primary completion: 2030-03-01
• Completion: 2035-03-01
• First posted: 2026-03-25
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States