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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

NCT07493538 · Masonic Cancer Center, University of Minnesota
In plain English

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About this study
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
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
Study design
Enrollment target: 132 participants
Allocation: na
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2026-04-10
Estimated completion: 2035-03
Last updated: 2026-04-16
Interventions
Drug: TreosulfanDrug: FludarabineRadiation: Total Body IrradiationDrug: TacrolimusDrug: Mycophenolate MofetilDrug: CyclophosphamidBiological: Stem Cell Infusion
Primary outcomes
  • Overall Survival (Day 100)
Sponsor
Masonic Cancer Center, University of Minnesota · other
Contacts & investigators
ContactChristopher Graham, MD · contact · grah0329@umn.edu · 612-625-3051
All locations (1)
Masonic Cancer Center at University of MinnesotaRecruiting
Minneapolis, Minnesota, United States
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 · TrialPath