Study on Using Donor Blood Stem Cells for Transplant: Focusing on Immune System Checkpoints

Sponsor: Dartmouth-Hitchcock Medical Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03480360

Provider View

This clinical trial is exploring the use of donor blood stem cells for transplantation in patients with certain blood-related diseases. The study aims to understand how the immune system, particularly immune checkpoints, responds after the transplant.

Patient Parameters

Program Overview

The study uses a standard treatment method from Johns Hopkins, involving donor blood stem cells instead of bone marrow. The main goal is to see how well patients do after a related donor stem cell transplant, focusing on how the immune system rebuilds itself, especially the parts that control immune responses called immune checkpoints.

Description

This clinical trial aims to achieve several goals:

  1. Determine key outcomes like how well the transplant takes, survival rates at 100 days, and survival rates at one year after the transplant.
  2. Study the presence and role of immune checkpoint regulators in the blood and bone marrow of patients after the transplant.
  3. Link these lab findings with patient outcomes and the occurrence of graft-versus-host disease (GVHD), a condition where the donor cells attack the patient's body.
  4. For patients who develop GVHD and need treatment, the study will explore how often and how strongly these immune checkpoints are expressed and how this relates to their response to GVHD treatment.

Eligibility Criteria

Inclusion Criteria

  • Be under 75 years old.
  • Approved for transplant by the transplant doctor, including completing all necessary pre-transplant evaluations.
  • Have a disease that can benefit from a stem cell transplant, such as:
    • Acute or chronic leukemia
    • Myelodysplasia or myeloproliferative disorders
    • Myelofibrosis
    • Lymphoma (Non-Hodgkin's or Hodgkin's)
    • Plasma cell disorders like myeloma or Waldenstrom's Macroglobulinemia
  • Have a related donor who is a partial match.
  • No HIV or active hepatitis B or C infections.
  • Be in good general health with a performance status of 0-2.
  • Have adequate lung and heart function.
  • Normal liver function tests.
  • No active or uncontrollable infections.
  • Women must have a negative pregnancy test if they are of childbearing age.
  • No major organ problems that would prevent a transplant.
  • No active cancer that would limit life expectancy to less than 2 years.

Exclusion Criteria

  • Severe psychiatric or mental health issues that would prevent understanding or following the treatment plan.
  • Major health problems that would make surviving a bone marrow transplant unlikely.
  • History of serious infections that don't respond to treatment.

DONOR ELIGIBILITY

  • Must be a partial match with the patient based on specific genetic markers.
  • Must be healthy and willing to donate, following standard guidelines.
  • No significant health issues that would increase the donor's risk.
  • No age limit for donors.
  • Must sign an informed consent form.

DONOR EXCLUSION CRITERIA

  • Pregnant or breastfeeding donors are not eligible.
  • Donors with HIV or active hepatitis B or C are not eligible.
  • Donors who cannot safely receive certain medications or undergo the donation process.
  • Donors with severe psychiatric or mental health issues that prevent understanding or following the donation process.

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