A prospective clinical trial of GVHD prophylaxis with posttransplant cyclophosphamide and abatacept
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Le résumé fourni par la source
ABSTRACT: We conducted a prospective randomized clinical trial to investigate the combination of posttransplant cyclophosphamide (PTCy) and abatacept (Aba) for graft-versus-host disease (GVHD) prophylaxis. Patients with hematologic malignancies undergoing an allogeneic transplant from an 8/8 matched related or unrelated donor were randomized 1:1 to tacrolimus and methotrexate (standard-of-care arm [SOC]) or PTCy on days +3 and +4, followed by Aba on an extended schedule: days +5, +14, and +28, and every 4 weeks up to day +168 (PTCy+Aba). All patients received peripherally collected stem cells. The primary end point was moderate and severe chronic GVHD at 1 year. Following US Food and Drug Administration approval of Aba for GVHD prophylaxis leading to change in institutional SOC, the trial was amended to enroll only on the PTCy+Aba arm. A total of 25 patients enrolled on PTCy+Aba, and 15 on SOC. The trial met its primary end point: Kaplan-Meier estimates of moderate and severe chronic GVHD were 0% on the PTCy+Aba and 65.8% on the SOC arm (P < .0001). GVHD-free, relapse-free survival (GRFS) was 62.5% on PTCy+Aba and 24.1% on SOC (P = .010). There were no treatment-related deaths on PTCy+Aba and 2 on SOC. Overall survival (PTCy+Aba, 92%; SOC, 80%; P = .28), disease-free survival (PCTy+Aba, 68%; SOC, 92.9%; P = .105), and infection rates at 1 year were similar. Grade 3/4 acute GVHD rate was 4.2% on PTCy+Aba and 21.4% on SOC (P = .092). PTCy+Aba preserved regulatory T-cell proliferation and increased CD16+CD56dim cytotoxic natural killer cells. In conclusion, PTCy+Aba is well tolerated and associated with reduced chronic GVHD and improved GRFS. This trial was registered at www.ClinicalTrials.gov as #NCT03680092.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- A prospective clinical trial of GVHD prophylaxis with posttransplant cyclophosphamide and abatacept
- Date Crossref
- 26/08/2025
- Éditeur
- American Society of Hematology
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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University of California San Diego Department of Medicine pays non établi dans la noticeUniversité ou école supérieure
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Sarah Cannon pays non établi dans la noticeStructure de recherche
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nView Medical (United States) pays non établi dans la noticeEntreprise
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Moores Cancer Center pays non établi dans la noticeÉtablissement de santé
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University of California San Diego Medical Center pays non établi dans la noticeÉtablissement de santé
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Cedars-Sinai Medical Center pays non établi dans la noticeÉtablissement de santé
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Rady Children's Hospital-San Diego pays non établi dans la noticeÉtablissement de santé
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UCSD pays non établi dans la noticeInstitution
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UC San Diego pays non établi dans la noticeInstitution
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Clinical and Translational Science Institute and Samuel Oschin Comprehensive Cancer Institute pays non établi dans la noticeStructure de recherche
Department of Medicine — University of California San Diego, Sarah Cannon et nView Medical (United States), avec 7 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.