Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Unrelated Donor for the Treatment of Hematological Diseases
Masonic Cancer Center, University of Minnesota
Summary
This is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a myeloablative preparative regimen (of either total body irradiation (TBI); or, fludarabine/busulfan for patients unable to receive further radiation). followed by a post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).
Eligibility
- Age range
- Up to 60 years
- Sex
- All
- Healthy volunteers
- No
-Inclusion Criteria: * Age: ≤ 60 years of age * Performance Status: Karnofsky ≥ 70%, Lansky play score ≥ 70 * Consent: Voluntary written consent (adult or legally authorized representative; or parental/guardian) * Adequate Organ Function: * Renal: Creatinine \<2x upper limit of normal. Patients above this limit must have creatinine clearance ≥ 40 ml/min/1.73m2 as determined by an age-appropriate method, such as cystatin C GFR. * Hepatic: Bilirubin, AST, alkaline phosphatase \<4 times the upper limit of institutional normal * Pulmonary: Diffusion capacity of oxygen, corrected for hemogl…
Interventions
- BiologicalHSCT with TBI Regimen
Day -5 to -2: Total Body Irradiation Day 0: Hematopoietic Stem Cell Transplantation Day +3 to +4: Cyclophosphamide Day +5: Tacrolimus from day +5 until taper day +100 (day +60 for peds if no acute or chronic GVHD present) Day +5: Mycophenolate mofetil through day +35 or 7 days after engraftment, whichever day is later, if no acute GVHD
- BiologicalHSCT with Non-TBI Regimen
Day -5 to Day -2: Busulfan and Fludaribine Day 0: Hematopoietic Stem Cell Transplantation Day +3 to +4: Cyclophosphamide Day +5: Tacrolimus from day +5 until taper day +100 (day +60 for peds if no acute or chronic GVHD present) Day +5: Mycophenolate mofetil through day +35 or 7 days after engraftment, whichever day is later, if no acute GVHD
Location
- Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota