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RECRUITING
NCT03314974
PHASE2

Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

Sponsor: Masonic Cancer Center, University of Minnesota

View on ClinicalTrials.gov

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).

Official title: Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Unrelated Donor for the Treatment of Hematological Diseases

Key Details

Gender

All

Age Range

Any - 60 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2018-03-30

Completion Date

2027-06-10

Last Updated

2025-06-24

Healthy Volunteers

No

Interventions

BIOLOGICAL

HSCT 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

BIOLOGICAL

HSCT 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

Locations (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, United States