NCT07493538PHASE2Recruiting
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
Masonic Cancer Center, University of Minnesota
Start Date
4/10/2026
Completion Date
3/1/2035
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.
Eligibility Criteria
Age Range: 2 years to 75 years
Inclusion Criteria:
* Patients 2-75 years of age
* ≤7 5 years of age: Karnofsky score ≥ 70% (≥ 16 years) or Lansky play score ≥ 50 (\< 16 years) with appropriate organ criteria as below (in other inclusion criteria)
* 5/6 or 6/6 related donor, OR a 5-8/8 HLA-A, B, C, DRB1 allele match unrelated donor, OR a haplotype (at least 5/10) related donor
* adequate liver (no decompensated liver failure, Child Pugh A, AST/ALT \<5X ULN) and renal function (creatinine \<2.0)
* absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction ≥ 40%
* DLCO FEV1, FVC ≥ 40% predicted, and absence of O2 requirement
Exclusion Criteria:
* Pregnant or breastfeeding
* Evidence of untreated/uncontrolled HIV infection
* Untreated active serious infection
* Active CNS malignancy
* CML in blast crisis not in a complete remission by abnormal blast count.
* Less than 3 months since prior myeloablative transplant
Interventions
DRUG
Treosulfan
DRUG
Fludarabine
RADIATION
Total Body Irradiation
DRUG
Tacrolimus
DRUG
Mycophenolate Mofetil
DRUG
Cyclophosphamid
BIOLOGICAL
Stem Cell Infusion
Conditions
AMLMDSAcute LeukemiaAcute Myeloid LeukemiaMyelodysplastic Syndromes
Locations
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota 55455
United States