Trial reportJournal of hematology & oncology2014
Multicenter phase II study of a combination of cyclosporine a, methotrexate and mycophenolate mofetil for GVHD prophylaxis: results of the Chinese Bone Marrow Transplant Cooperative Group (CBMTCG).
Trial report in Journal of hematology & oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers.
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Who cites it
43 citing papers in PubMed, 73 citations in OpenAlex.
- Outcomes of allogeneic haematopoietic stem cell transplantation for patients with severe aplastic anaemia using the porcine antilymphocyte globulin-containing conditioning regimen.Annals of hematology · 2020Trial
- Minimal residual disease- and graft-vs.-host disease-guided multiple consolidation chemotherapy and donor lymphocyte infusion prevent second acute leukemia relapse after allotransplant.Journal of hematology & oncology · 2016Trial
- Plerixafor (a CXCR4 antagonist) following myeloablative allogeneic hematopoietic stem cell transplantation enhances hematopoietic recovery.Journal of hematology & oncology · 2016Trial
- Donor-specific anti-human leukocyte antigen antibodies were associated with primary graft failure after unmanipulated haploidentical blood and marrow transplantation: a prospective study with randomly assigned training and validation sets.Journal of hematology & oncology · 2015Trial
- Outcomes of patients with hematological malignancies complicated with autoimmune diseases after allogeneic hematopoietic stem cell transplantation: A ten-year real-world study.Journal of translational internal medicine · 2026Article
- Cyclosporine in hematological disorders: mechanisms, clinical practice and emerging advances.Annals of hematology · 2026Review
- [Guideline for allogeneic hematopoietic stem cell transplantation in the treatment of transfusion-dependent thalassemia in China (2026)].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2026Article
- Novel insights from a large cohort: Elucidating incidence, risk factors, treatment, and prognostic predictors in autoimmune hemolytic anemia after allogeneic hematopoietic stem cell transplantation.Journal of translational internal medicine · 2026Article
- [Identifying risk factors for acute graft-versus-host disease in patients with acute myeloid leukemia undergoing haploidentical hematopoietic stem cell transplantation].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2025Article
- Impact of cyclosporine A-related single nucleotide polymorphisms on post-transplant outcomes in pediatric hematologic malignancy patients undergoing allogeneic hematopoietic stem cell transplantation.Frontiers in immunology · 2025Article
- Clinical characteristics of membranous nephropathy after allogeneic hematopoietic stem cell transplantation: A real-world multicenter study.Annals of hematology · 2024Article
- Early Post-Transplant Serum Ferritin Levels as Predictive Biomarkers for Severe Acute Graft-Versus-Host Disease in Pediatric Umbilical Cord Blood Transplantation for Acute Leukemia.Annals of transplantation · 2024Article
- [Chinese expert consensus on the diagnosis and treatment of acute graft-versus-host disease after hematopoietic stem cell transplantation (2024)].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2024Article
- Outcomes and prognosis of haploidentical haematopoietic stem cell transplantation in children with FLT3-ITD mutated acute myeloid leukaemia.Bone marrow transplantation · 2024Article
- Article
- Clinical risk factors and prognostic model for patients with bronchiolitis obliterans syndrome after hematopoietic stem cell transplantation.Bone marrow transplantation · 2024Article
- Porcine Anti-Lymphocyte Globulin, Cyclosporine A Plus Thrombopoietin Receptor Agonists Achieved Similar Efficacy and Survival Compared to Allogeneic Hematopoietic Stem Cell Transplantation in Patients with Aplastic Anemia.International journal of general medicine · 2024Article
- Using T-lymphocyte subsets at engraftment to predict the risk of acute graft-versus-host disease in patients with thalassemia major: development of a new predictive nomogram.Therapeutic advances in hematology · 2024Article
- Human leukocyte antigen evolutionary divergence as a novel risk factor for donor selection in acute lymphoblastic leukemia patients undergoing haploidentical hematopoietic stem cell transplantation.Frontiers in immunology · 2024Article
- Real-world outcomes and prognostic factors among patients with acute myeloid leukemia treated with allogeneic hematopoietic stem cell transplantation.Annals of hematology · 2023Article
Corrections and comments
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Authors and funding
12 authors at 10 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundImprovement of current GVHD prophylactic therapies remains an important goal in the allo-HSCT. We have described a novel prophylaxis regimen in a single institution trial. The Chinese Bone Marrow Transplant Cooperative Group (CBMTCG) initiated a phase II multicenter study.
methodsThe study was designed as a prospective, single arm phase II open-label, multicenter clinical trial. The primary endpoint was improvement of aGVHD by 25% over historical control (40%) in Chinese patients. 508 patients were enrolled. All of the patients received cyclosporine A (CsA), methotrexate (MTX) and mycophenolate mofetil (MMF) (0.5-1.0 g daily for 30 days) as GVHD prophylaxis regimen.
resultsThe primary endpoint was met with cumulative incidences of grades 2 to 4 and grades 3 to 4 aGVHD of 23.2% and 10.3%, respectively. Incidence for cGVHD was 67.4%. The non-relapse mortality (NRM) rate was 18.4% at 2 years. The probabilities of leukemia free survival (LFS) for non-advanced stage and advanced stage patients at 2 years were 69.7% and 44.8% respectively (p = 0.000). Recipient age ≥ 40 years, advanced stage and Busulfan-Fludarabine(BuFlu) conditioning regimen were identified as major risk factors for aGVHD. Recipient age ≥ 40 years, BuFlu conditioning regimens, female donor/male recipient and prior aGVHD were associated with cGVHD. Despite lower RM (relapse mortality), patients with grade 2-4 aGVHD had higher NRM and worse OS and LFS compared to patients with grade 0-1 aGVHD. In contrast, patients with cGVHD had better OS and LFS and lower RM compared to patients without cGVHD.
conclusionThe novel GVHD regimen decreased the risk for aGVHD by 42% without improving the risk for cGVHD compared to historical controls. Development of aGVHD was associated with worse OS and LFS as well as higher NRM. In contrast, cGVHD was associated with improved OS and LFS likely attributed to a GVL effect.
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