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

Age range

2–75 years

Sex

All

Healthy volunteers

No

Interventions

• 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

Location