Study on Abatacept with Cord Blood Transplant for Preventing Acute Graft Versus Host Disease

Sponsor: Leland Metheny

Sponsor score: 40

ClinicalTrials ID:NCT06680661

Provider View

This clinical trial is testing whether adding the drug abatacept to standard treatments can help prevent or reduce acute graft versus host disease (aGVHD) in patients with blood cancer undergoing a cord blood transplant.

Patient Parameters

Program Overview

The aim of this study is to find out if adding abatacept to the usual medications, tacrolimus and MMF, can prevent or lessen the chances of acute graft versus host disease (aGVHD) after a cord blood transplant in patients with blood cancer. aGVHD is a complication that can occur after a transplant. Participants will undergo exams, tests, and procedures as part of their regular cancer care, receive treatment before the transplant (conditioning), have a cord blood transplant, and receive radiation therapy after the transplant.

Description

Cord blood is a valuable source for transplants in patients with blood cancers who do not have a matching adult donor. It is especially useful for Black, Asian, and Hispanic populations, who have lower chances of finding a match. Cord blood allows for more differences between donor and recipient, increasing donor availability. However, recipients of double cord blood transplants (dCBT) have a high rate of acute graft versus host disease (aGVHD), which is a complication where the donor cells attack the recipient's body. This study is testing if abatacept can safely reduce the rates of aGVHD in these patients. Previous studies have shown that abatacept can reduce aGVHD in other types of transplants. The study will evaluate if it is effective and safe for patients receiving dCBT.

Eligibility Criteria

Inclusion Criteria

  • Patients with certain blood cancers, such as:
    • Acute myelogenous leukemia (AML) with specific risk factors or treatment history
    • Acute lymphoblastic leukemia (ALL) with specific risk factors or treatment history
    • Myelodysplastic syndromes (MDS) with certain risk levels
    • Bi-phenotypic or mixed-phenotypic acute leukemia
    • Chronic Myelogenous Leukemia (CML) in a specific phase
    • Chronic Myelomonocytic Leukemia (CMML)
  • Aged 18 to 65 years
  • Good physical condition (KPS score of 80 or higher)
  • No suitable HLA-matched donor available
  • Have specific cord blood units available for transplant
  • May receive additional therapy for certain types of leukemia or lymphoma if needed
  • Must understand and agree to the study requirements and sign a consent form

Exclusion Criteria

  • Poor organ function, such as:
    • Low kidney function
    • High bilirubin levels (unless due to Gilbert syndrome)
    • High liver enzyme levels
    • Poor lung function
    • Low heart function
  • Uncontrolled illnesses, such as infections or heart problems
  • Pregnant or breastfeeding women
  • Any condition that would interfere with participation or pose a risk
  • Allergies to study medications
  • Presence of antibodies against the donor source
  • High comorbidity index score
  • Recent prior stem cell transplant

Locations

FACILITYZIPCITYSTATE
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center44106ClevelandOhio

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.