ABBA CORD: Abatacept for aGVHD Prevention in Cord Blood Transplant
This study is testing if adding abatacept to standard medications (tacrolimus and MMF) can help prevent or reduce acute graft versus host disease (aGVHD) after a double umbilical cord blood transplant. aGVHD is a common complication where the new immune cells attack your body. The study is for people aged 18-65 with certain blood cancers like acute myeloid leukemia (AML) or acute lymphatic leukemia (ALL). Researchers want to see if abatacept is safe and effective in lowering aGVHD rates. Success will be measured by how many people are free from severe aGVHD 180 days after treatment. The study plans to enroll 20 participants, but its current status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 20 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would undergo exams, tests, and procedures as part of usual cancer care, receive conditioning treatment before transplant, have a cord blood transplant, and undergo radiation after the transplant.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed to measure severe aGVHD free survival at 180 days after treatment.
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NCT06680661
ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis
Recruiting
PHASE2Ages 18–65InterventionalTreatmentLeland MethenyInvestigator-initiated
~20 participants
Updated 2025-06-04 on ClinicalTrials.gov
What's tested:CyclophosphamideFludarabineThiotepaTotal Body IrradiationDouble Umbilical Cord TransplantTacrolimus
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Severe aGVHD free survival
Measured over 180 days after treatment
Conditions
Where it's being run
1 sites across 1 statesOhio1
Study leadership
- Leland Metheny, MD · PRINCIPAL_INVESTIGATOR · University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
Patient with the following CB units:
At least two 4-8/8 HLA high resolution matched CB units. Both must have a cell dose of 1.5x107 TNC/kg each and 1.5x105 CD34+/kg
A minimum of 1 CB unit as back up.
Concurrent Therapy for Extramedullary Leukemia or CNS Lymphoma: Concurrent therapy or prophylaxis for testicular leukemia, CNS leukemia, and CNS lymphoma including standard intrathecal chemotherapy and/or radiation therapy will be allowed as clinically indicated. Such treatment may continue until the planned course is completed. Subjects must be in CNS remission at the time of protocol enrollment if there is a history of CNS involvement. Maintenance therapy after transplant is allowed.
Subjects must have the ability to understand and the willingness to sign a written informed consent document.
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \< 1% per year during the treatment period and for 12 months after the last dose of abatacept.
A woman is considered to be of childbearing potential if she is \< 60 years old, postmenarcheal, has not reached a postmenopausal state (\< 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).
Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures with female partners of reproductive potential, and agreement to refrain from donating sperm, as defined below:
With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period and for 12 months after the last dose of abatacept. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 12 months after the last dose of abatacept.
The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
Exclusion
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.
What this trial measures
- Severe aGVHD free survival180 days after treatment
To assess severe aGVHD (grade III-IV acute GVHD) free survival (SGFS) at T+180.