Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases
Masonic Cancer Center, University of Minnesota
Summary
This is a Phase II study following subjects proceeding with our Institutional non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion using post-transplant cyclophosphamide (PTCy), sirolimus and MMF GVHD prophylaxis.
Eligibility
- Age range
- Up to 75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 0 to 75 years of age with Karnofsky score ≥ 70% (≥ 16 years) or Lansky score ≥ 50 (\< 16 years). * 5/6 or 6/6 related donor, OR a 7-8/8 HLA-A, B, C, DRB1 allele match, OR a haplotype (at least 5/10) matched related donor. Donors will be requested to provide PBSCs although bone marrow is acceptable according to donor preference. Eligible Diseases Acute Leukemias: Must be in remission by morphology (≤5% blasts) AND without evidence of MRD by flow cytometry, FISH, or conventional cytogenetics. PCR based MRD detection is not an exclusion to proceed. Acute Myeloid Leuke…
Interventions
- BiologicalPeripheral Blood Stem Cell Transplant
On day 0, a target dose of 5 x 106 CD34 cells/kg will be infused.
- DrugAllopurinol 300 MG
300 mg/day from day -7 to day 0. Allopurinol 150mg/m2/day for pediatric participants.
- DrugFludarabine
30 mg/m2 IV over 1 hour. Administered on day -6 to day -2.
- DrugCyclophosphamide
Administered as a 2 hour IV infusion on day -6, +3, and +4.
- BiologicalBone Marrow Cell Transplant
On day 0, a target dose of 3 x 108 nucleated cells/kg recipient weight will be infused.
- RadiationTotal Body Irradiation
The dose of TBI will be 200 cGy given in a single fraction on day -1.
Location
- Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota