Study on Two-Step ATG Treatment to Prevent Acute GVHD After Stem Cell Transplant

Sponsor: University of Alabama at Birmingham

Sponsor score: 0

ClinicalTrials ID:NCT06265584

Provider View

This clinical trial is testing a new approach to prevent a condition called graft versus host disease (GVHD) in patients receiving stem cell transplants. The study uses a two-step method of giving a medication called anti-thymocyte globulin (ATG) to improve outcomes after the transplant.

Patient Parameters

Program Overview

The purpose of this study is to see if a new way of giving a medication called anti-thymocyte globulin (ATG) can help prevent a condition called graft versus host disease (GVHD) in patients who have received a stem cell transplant. GVHD is a complication where the donor's immune cells attack the patient's body. The study will test if giving ATG in two steps, along with standard medications tacrolimus and mini methotrexate, can reduce the risk of severe GVHD and improve survival rates one year after the transplant.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 to 75 years.
  • Must have a related or unrelated donor who is a close genetic match and willing to donate stem cells.
  • Suitable for a less intense preparative regimen due to age (60 or older) or other health risks.
  • Heart function must be adequate, with an ejection fraction over 40%.
  • Kidney function must be good, with creatinine clearance over 50 mL/minute.
  • Lung function must be sufficient, with specific breathing test results over 50%.
  • Liver function must be within certain limits, with allowances for Gilbert's Disease.
  • Women of childbearing potential must use two forms of birth control or abstain from sex for 12 months after the transplant.
  • Men must use effective barrier contraception or abstain from sex for 12 months after the transplant.
  • Must have a performance status score of 70 or higher, indicating good overall health.
  • Must have a diagnosis of specific blood cancers, such as AML, MDS, or myelofibrosis, with certain characteristics.
  • Willing and able to sign informed consent and follow study requirements.

Exclusion Criteria

  • Had a previous stem cell transplant from their own cells within the last 3 months.
  • Have more than 5% cancer cells in the bone marrow or circulating in the blood.
  • Have had a previous stem cell transplant from a donor.
  • Have severe heart problems or abnormal heart rhythms.
  • Allergic to any of the study medications.
  • Have taken investigational drugs within 14 days before starting transplant preparation.
  • Pregnant or breastfeeding.
  • Have HIV infection.
  • Have an uncontrolled infection.
  • Have liver cirrhosis.
  • Have had another type of cancer within the last 3 years, except for certain skin cancers.
  • Participating in another clinical study with an investigational product in the last 28 days.

Locations

FACILITYZIPCITYSTATE
University of Alabama at Birmingham35294BirminghamAlabama

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