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

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

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

Conditions6

Interventions6

Locations1 site

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