ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis

Recruiting now · Phase 2

Conditions studied: Acute Myelogenous Leukemia, Acute Lymphatic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndromes, Myelodysplastic Syndrome Other, Chronic Myelomonocytic Leukemia, Lymphoma, Hodgkin Lymphoma

In brief

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.

Key facts

Study ID: NCT06680661
Run by: Leland Metheny
People needed: 20
Starts: 2025-02-25
Expected to finish: 2028-10-31
Last updated by the study team: 2025-06-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients with the following hematologic malignancies:
Acute myelogenous leukemia (AML): High-risk and intermediate-risk AML including:
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
Induction failure or 1st relapse with < 10% blasts in the marrow
Acute lymphoblastic leukemia (ALL):
High-risk CR1 including:
Poor-risk cytogenetics (e.g., Philadelphia chromosome t(9;22)or 11q23 rearrangements)
Philadelphia chromosome-like ALL
Presence of minimal disease by flow cytometry after 2 or more cycles of chemotherapy
No CR within 4 weeks of initial treatment
Induction failure with < 10% blasts in the marrow
CR2 or CR3
Myelodysplastic syndromes (MDS), Intermediate, High or Very High Risk by the revised international prognostic scoring system or treatment related MDS.
Bi-phenotypic or mixed-phenotypic acute leukemia in:
CR.
Induction failure or 1st relapse with < 10% blasts in the marrow.
Chronic Myelogenous Leukemia (CML) in second chronic phase after accelerated or blast crisis.
Chronic Myelomonocytic Leukemia (CMML)
Hodgkin's Lymphoma that is relapsed or refractory
Age > or equal to 18 years, < or equal to 70yrs
KPS > or equal to 80 for Flu/Cy/Thio/TBI; KPS > 60 for Flu/Treo/TBI
Patients without a suitable HLA-matched related or unrelated donor

You may not qualify if…

Patients with inadequate Organ Function as defined by:
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
Pulmonary function: DLCOc < 60% normal
Cardiac: left ventricular ejection fraction < 50
Patients with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant or breastfeeding women are excluded from this study because chemotherapy involved with RIC have the significant potential for teratogenic or abortifacient effects.
Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.
Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.
Presence of donor-specific antibodies against chosen graft source.
Hematopoietic Cell Transplantation Comorbidity index (HCT-CI) > 5.
Prior autologous or allogenic stem cell transplant within the preceding 12 months.

Where it is running

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.