Study on Using Reduced Intensity Conditioning and Stem Cell Transplant for Treating Blood Diseases

Sponsor: Masonic Cancer Center, University of Minnesota

Sponsor score: 40

ClinicalTrials ID:NCT07493538

Provider View

This clinical trial is testing a new approach to stem cell transplantation using a less intense preparation method for patients with blood diseases. The study aims to evaluate the safety and effectiveness of this treatment, which includes a combination of medications to prevent complications after the transplant.

Patient Parameters

Program Overview

This Phase II study is exploring a new method of stem cell transplantation for patients with blood diseases. The treatment involves preparing the body with a lower intensity regimen using the drug Treosulfan, followed by an infusion of stem cells from a donor. After the transplant, patients will receive medications, including cyclophosphamide, tacrolimus, and MMF, to help prevent complications such as graft-versus-host disease (GVHD). The study includes patients receiving stem cells from related, unrelated, or partially matched family donors.

Eligibility Criteria

Inclusion Criteria

  • Patients aged 2 to 75 years.
  • For patients 16 years and older, a Karnofsky score of 70% or higher; for those under 16, a Lansky play score of 50 or higher.
  • Must have a suitable donor match, which can be a related donor, an unrelated donor with a specific match, or a partially matched family donor.
  • Must have good liver and kidney function.
  • Must not have severe heart problems or uncontrolled heart rhythm issues, with a heart function of 40% or higher.
  • Must have adequate lung function and not require oxygen support.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Patients with untreated or uncontrolled HIV infection.
  • Patients with serious infections that are not being treated.
  • Patients with active cancer in the central nervous system.
  • Patients with chronic myeloid leukemia (CML) in blast crisis that is not in complete remission.
  • Patients who have had a myeloablative transplant within the last 3 months.

Locations

FACILITYZIPCITYSTATE
Masonic Cancer Center at University of Minnesota55455MinneapolisMinnesota

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