Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2011
Prophylaxis of graft-versus-host disease in unrelated donor transplantation with pentostatin, tacrolimus, and mini-methotrexate: a phase I/II controlled, adaptively randomized study.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
12 citing papers in PubMed, 28 citations in OpenAlex.
- Dose intensification of busulfan in the preparative regimen is associated with improved survival: a phase I/II controlled, randomized study.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2013Trial
- Blood and Marrow Transplant Clinical Trials Network Report on the Development of Novel Endpoints and Selection of Promising Approaches for Graft-versus-Host Disease Prevention Trials.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2018Article
- Pentostatin therapy for steroid-refractory acute graft versus host disease: identifying those who may benefit.Bone marrow transplantation · 2018Article
- The Role of Extracellular Adenosine Generation in the Development of Autoimmune Diseases.Mediators of inflammation · 2018Review
- Interactions Between Inflammatory Bowel Disease Drugs and Chemotherapy.Current treatment options in gastroenterology · 2016Review
- Approaches for the prevention of graft-versus-host disease following hematopoietic cell transplantation.International journal of hematologic oncology · 2015Article
- Current and emerging strategies for the prevention of graft-versus-host disease.Nature reviews. Clinical oncology · 2014Review
- Significance of persistent cytogenetic abnormalities on myeloablative allogeneic stem cell transplantation in first complete remission.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2013Article
- Graft-versus-host disease: state of the science.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2013Review
- Anti-thymocyte globulin (thymoglobulin), tacrolimus, and sirolimus as acute graft-versus-host disease prophylaxis for unrelated hematopoietic stem cell transplantation.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2012Article
- Prevention of graft-vs.-host disease.Expert opinion on pharmacotherapy · 2012Review
- Have we improved in preventing and treating acute graft-versus-host disease?Current opinion in hematology · 2011Review
Corrections and comments
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Authors and funding
20 authors at 1 institution in 1 country.
Funding
Abstract
purposeAcute graft-versus-host disease (aGVHD) is a major cause of morbidity and mortality after matched unrelated, related, or mismatched related donor hematopoietic stem-cell transplantation (HSCT). Improved GVHD prevention methods are needed. Pentostatin, an adenosine deaminase inhibitor, leads to lymphocyte depletion with low risk of myelosuppression. We hypothesized that addition of pentostatin to GVHD prophylaxis with tacrolimus and mini-methotrexate may improve outcomes, and we conducted a Bayesian adaptively randomized, controlled, dose-finding study, taking into account toxicity and efficacy. PATIENTS AND
methodsSuccess was defined as the patient being alive, engrafted, in remission, without GVHD 100 days post-HSCT and no grade ≥ 3 GVHD at any time. Patients were randomly assigned to pentostatin doses of 0, 0.5, 1.0, 1.5, and 2.0 mg/m(2) with drug administered on HSCT days 8, 15, 22, and 30. Eligible patients were recipients of mismatched related (n = 10) or unrelated (n = 137) donor HSCT.
resultsMedian age was 47 years. Thirty-seven, 10, 29, 61, and 10 patients were assigned to the control and four treatment groups, respectively, with comparable baseline characteristics. Pentostatin doses of 1.0 and 1.5 mg/m(2) had the highest success rates (69.0% and 70.5%) versus control (54.1%). The posterior probabilities that the success rates were greater with 1.5 mg/m(2) or 1.0 mg/m(2) versus control are 0.944 and 0.821, respectively. Hepatic aGVHD rates were 0%, 17.2%, and 11.1%, respectively, for 1.5 mg/m(2), 1.0 mg/m(2), and control groups. No grades 3 to 4 aGVHD occurred in 11 HLA-mismatched recipients in the 1.5 mg/m(2) group.
conclusionPentostatin increased the likelihood of success as defined here, and should be further investigated in larger randomized, confirmatory studies.
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