ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLeland Metheny

About this trial

The goal of this clinical trial is to see if adding abatacept to tacrolimus and MMF prevents or reduces the chances of acute graft versus host disease which is a complication that can occur after transplant in participants with blood cancer. The usual therapy for graft versus host disease prevention after a cord blood transplant includes tacrolimus and MMF. The main question this clinical trial aims to answer is whether or not abatacept will be safe and effective in reducing aGVHD rates in dCBT.

Participants will:

* Partake in exams, tests, and procedures as part of usual cancer care. * Partake in conditioning, which is the treatment that is given before a transplant. * Have a cord blood transplant. * Partake in radiation following the transplant.

Eligibility criteria

Qualifiers

Antecedent hematological disease (e.g., myelodysplasia (MDS))

Treatment-related leukemia

Complete Remission (CR1) with poor or intermediate-risk cytogenetics or molecular markers (e.g. Flt 3 mutation, 11q23, del 5, del 7, complex cytogenetics)

CR2 or CR3

Disqualifiers

Creatinine clearance < 50ml/min

Bilirubin > 2X institutional upper limit of normal unless Gilbert syndrome

AST (SGOT) > 3X institutional upper limit of normal

ALT (SGPT) > 3X institutional upper limit of normal

Trial design

Treatments tested in this trial

  • Cyclophosphamide
  • Fludarabine
  • Thiotepa
  • Total Body Irradiation
  • Double Umbilical Cord Transplant
  • Tacrolimus
  • Mycophenolate Mofetil
  • Abatacept

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

Leland Metheny

Lead sponsor

Case Comprehensive Cancer Center

Sponsor institution