Phase 2
Completed N=10
Pilot of Abatacept-based Immunosuppression for Prevention of Acute GvHD During Unrelated Donor HCT
Source: ClinicalTrials.gov NCT01012492 ↗Enrolled (actual)
10
Serious AEs
70.0%
Results posted
Sep 2017
Primary outcomePrimary: Percentage of Participants With Grade III-IV Acute GVHD by Day 100. — 10 percentage of participants
Summary
The primary objective of the study is to determine the safety and tolerability when adding abatacept to acute Graft versus Host Disease in transplants for malignant diseases using unrelated donor bone marrow or peripheral blood stem cell grafts.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Grade III-IV Acute GVHD by Day 100. |
10 | — |
| SECONDARY Percentage of Participants With Grades III-IV Acute GVHD at 2 Years |
10 | — |
| SECONDARY Hematologic and Immunologic Reconstitution |
285 | — |
| SECONDARY Protective Immunity |
2.8 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with AML, with or without a history of myelodysplastic syndrome in one of the following categories.
(a) Patients in first complete remission with high-risk features
- Patients with ALL, in either of the following categories:
- In 2nd or greater complete remission (complete remission is defined as > 5% blasts in marrow)
- Delayed 1st CR-Failure to achieve complete remission after a single round of induction therapy
- Patients with undifferentiated or biphenotypic leukemia in 1st or greater complete remission.
- Patients with Myelodysplastic Syndrome(s) with an IPSS score of >1.5 and 2 courses of induction chemotherapy to achieve remission status.
- HIV infection
- Tuberculosis Infection
- Chronic Obstructive Pulmonary Disease
- Pregnancy (positive serum b-HCG) or breastfeeding
- Creatinine clearance or nuclear medicine GFR of 2 × upper limit of normal or ALT > 4 × upper limit of normal or unresolved veno-occlusive disease.
- Pulmonary disease with FVC, FEV1 or DLCO parameters <45% predicted (corrected for hemoglobin) or O2 saturation <92% on room air.
- Karnofsky performance score or Lansky Play-Performance Scale <80
- Uncontrolled viral, bacterial, or fungal infection at the time of study enrollment
- Availability of a willing and fully MHC-matched related donor.
- Positive cytotoxic recipient-donor cross-match or positive HLA antibody screen against donor-disparate antigens.
- Any active infection.
- Unable to obtain informed consent.
Data sourced from ClinicalTrials.gov (NCT01012492). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.