Study on Myeloablative Stem Cell Transplant with Donor for Blood Disorders

Sponsor: Masonic Cancer Center, University of Minnesota

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03314974

This clinical trial is exploring a type of stem cell transplant using high-dose treatments to prepare the body, followed by a donor stem cell transplant to treat various blood disorders. The study also includes medications to prevent complications after the transplant.

Patient Parameters

Program Overview

This study is testing a treatment called allogeneic hematopoietic stem cell transplant (HCT) for people with certain blood disorders. The treatment involves using high-dose therapy to prepare the body, followed by a transplant of stem cells from a donor. After the transplant, patients will receive medications to help prevent a condition called graft-versus-host disease (GVHD), which can occur when the donor cells attack the patient's body. The study aims to find out if this approach is safe and effective for treating blood disorders.

Eligibility Criteria

Inclusion Criteria

  • Age 60 or younger.
  • Good overall health with a performance status score of 70% or higher.
  • Able to give written consent to participate.
  • Adequate organ function, including:
    • Kidney function within normal limits or creatinine clearance of at least 40 ml/min.
    • Liver function with bilirubin, AST, and alkaline phosphatase less than 4 times the normal limit.
    • Lung function with oxygen diffusion capacity over 50% or oxygen saturation over 95% for children.
    • Heart function without severe heart failure or uncontrolled arrhythmia, and ejection fraction over 45%.
    • HIV infection with undetectable viral load and a management plan in place.
  • Women and men of childbearing potential must use effective birth control during treatment.
  • Must have a suitable donor for the transplant.
  • Eligible blood disorders include:
    • Acute leukemias in remission or with specific risk factors.
    • Chronic myelogenous leukemia not responding to certain treatments.
    • Plasma cell leukemia after initial therapy.
    • Myeloproliferative neoplasms with intermediate or high risk.
    • Myelodysplastic syndromes with high risk features.
    • Chronic lymphocytic leukemia and other lymphomas with specific criteria.
    • Multiple myeloma with certain risk factors.
    • Other specific blood disorders as outlined in the study.

Exclusion Criteria

  • Certain types of chemotherapy-resistant lymphomas.
  • Chronic myelogenous leukemia in blast crisis.
  • Lymphomas progressing on salvage therapy.
  • Active cancer in the central nervous system.
  • Recent myeloablative transplant in children or previous transplant in adults.
  • Active or uncontrolled HIV infection.
  • Active, uncontrolled infections.
  • Pregnant or breastfeeding women, due to potential harm to the fetus.

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