Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT03314974
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • HSCT with TBI Regimen — BIOLOGICAL
    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
  • HSCT with Non-TBI Regimen — BIOLOGICAL
    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

Study Details

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).

Key Dates

Start date
Mar 30, 2018
Status verified
Jun 2025
Primary completion
Jun 10, 2026
Completion
Jun 10, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TBI Regimen
  • Experimental: Non-TBI Regimen

Primary Outcome Measure

Chronic GVHD - 1 year [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Masonic Cancer Center at University of MinnesotaMinneapolisMinnesota55337
Tamy Grainger, RN
[email protected]
612-273-2800

Find similar trials in Minneapolis, MN

By condition
Leukemia (other)Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Masonic Cancer Center at University of Minnesota· Minneapolis, MN

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