NCT03314974

Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute Leukemia
• Acute Myeloid Leukemia
• Acute Lymphoblastic Leukemia
• Lymphoma
• Chronic Myelogenous Leukemia
• Plasma Cell Leukemia
• Myeloproliferative Neoplasms
• Myelofibrosis
• Myelodysplasia
• Refractory Anemia
• High Risk Anemia
• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma
• Marginal Zone B-Cell Lymphoma
• Follicular Lymphoma
• Lymphoplasmacytic Lymphoma
• Mantle-Cell Lymphoma
• Prolymphocytic Leukemia
• Diffuse Large Cell Non Hodgkins Lymphoma
• Lymphoblastic Lymphoma
• Burkitt Lymphoma
• High Grade Non-Hodgkin's Lymphoma, Adult
• Multiple Myeloma
• Juvenile Myelomonocytic Leukemia
• Biphenotypic/Undifferentiated/Prolymphocytic Leukemias
• MRD Positive Leukemia
• Natural Killer Cell Malignancies
• Acquired Bone Marrow Failure Syndromes

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-03-30
• Primary completion: 2026-06-10
• Completion: 2027-06-10
• First posted: 2017-10-19
• Last updated: 2025-06-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study