Actively Recruiting

Phase 2
Age: 0 - 60Years
All Genders
NCT03314974

Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

Led by Masonic Cancer Center, University of Minnesota · Updated on 2025-06-24

300

Participants Needed

1

Research Sites

479 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

Who Can Participate

Age: 0 - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 60 years or younger
  • Karnofsky or Lansky performance status of 70% or higher
  • Voluntary written consent provided by adult, legally authorized representative, or parent/guardian
  • Adequate kidney function: creatinine less than twice the upper limit of normal or creatinine clearance at least 40 ml/min/1.73m2
  • Adequate liver function: bilirubin, AST, and alkaline phosphatase less than 4 times the upper limit of normal
  • Adequate lung function: oxygen diffusion capacity greater than 50% or oxygen saturation over 95% on room air for pediatric patients unable to perform lung tests
  • Adequate heart function: no decompensated heart failure or uncontrolled arrhythmia, and left ventricular ejection fraction over 45%
  • HIV infection allowed only if viral load is undetectable and management plan established
  • Women of childbearing potential and sexually active males with partners of childbearing potential must use effective birth control during treatment
  • Availability of a suitable donor graft according to University of Minnesota Blood and Marrow Transplantation Program criteria
  • Eligible hematological diseases in specified remission or risk statuses as detailed in protocol
Not Eligible

You will not qualify if you...

  • Chemotherapy refractory large cell and high-grade non-Hodgkin lymphoma with progressive disease after more than two salvage regimens
  • Chronic myeloid leukemia in blast crisis
  • Large cell lymphoma, mantle cell lymphoma, and Hodgkin disease progressing on salvage therapy
  • Evidence of progressive disease by imaging or biopsy, except persistent PET activity without CT changes
  • Active central nervous system malignancy
  • Prior myeloablative transplant within last 6 months if age 18 or younger; prior myeloablative allotransplant or autologous transplant if older than 18
  • Active HIV infection or known positive HIV serology without viral control
  • Active uncontrolled infection
  • Pregnant or breastfeeding females; females of childbearing potential must have negative pregnancy test before therapy start

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, United States, 55337

Actively Recruiting

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Research Team

T

Tamy Grainger

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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