The DOI matches its Crossref record; 18 of the 18 references it cites were found in a registry or an index.
Prospective, Randomized, Double-Blind, Phase III Clinical Trial of Anti–T-Lymphocyte Globulin to Assess Impact on Chronic Graft-Versus-Host Disease–Free Survival in Patients Undergoing HLA-Matched Unrelated Myeloablative Hematopoietic Cell Transplantation
Open accessAbstract
Purpose: Several open-label randomized studies have suggested that in vivo T-cell depletion with anti–T-lymphocyte globulin (ATLG; formerly antithymocyte globulin-Fresenius) reduces chronic graft-versus-host disease (cGVHD) without compromising survival. We report a prospective, double-blind phase III trial to investigate the effect of ATLG (Neovii Biotech, Lexington, MA) on cGVHD-free survival. Patients and Methods: Two hundred fifty-four patients 18 to 65 years of age with acute leukemia or myelodysplastic syndrome who underwent myeloablative HLA-matched unrelated hematopoietic cell transplantation (HCT) were randomly assigned one to one to placebo (n =128 placebo) or ATLG (n = 126) treatment at 27 sites. Patients received either ATLG or placebo 20 mg/kg per day on days −3, −2, −1 in addition to tacrolimus and methotrexate as GVHD prophylaxis. The primary study end point was moderate-severe cGVHD-free survival. Results: Despite a reduction in grade 2 to 4 acute GVHD (23% v 40%; P = .004) and moderate-severe cGVHD (12% v 33%; P < .001) in ATLG recipients, no difference in moderate-severe cGVHD-free survival between ATLG and placebo was found (2-year estimate: 48% v 44%, respectively; P = .47). Both progression-free survival (PFS) and overall survival (OS) were lower with ATLG (2-year estimate: 47% v 65% [ P = .04] and 59% v 74% [ P = .034], respectively). Multivariable analysis confirmed that ATLG was associated with inferior PFS (hazard ratio, 1.55; 95% CI, 1.05 to 2.28; P = .026) and OS (hazard ratio, 1.74; 95% CI, 1.12 to 2.71; P = .01). Conclusion: In this prospective, randomized, double-blind trial of ATLG in unrelated myeloablative HCT, the incorporation of ATLG did not improve moderate-severe cGVHD-free survival. Moderate-severe cGVHD was significantly lower with ATLG, but PFS and OS also were lower. Additional analyses are needed to understand the appropriate role for ATLG in HCT.
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Acute graft-versus-host disease
Malard, F., Holler, E., Sandmaier, B. M., Huang, H., & Mohty, M. (2023) · Nature Reviews Disease Primers · doi:10.1038/s41572-023-00438-1 · Cited by 268
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Retracted
Metadata
- Authors
- Soiffer, R. J., Kim, H. T., McGuirk, J., Horwitz, M. E., Johnston, L., Patnaik, M. M., Rybka, W., Artz, A., Porter, D. L., Shea, T. C., Boyer, M. W., Maziarz, R. T., Shaughnessy, P. J., Gergis, U., Safah, H., Reshef, R., DiPersio, J. F., Stiff, P. J., Vusirikala, M., Szer, J., Holter, J., Levine, J. D., Martin, P. J., Pidala, J. A., Lewis, I. D., Ho, V. T., Alyea, E. P., Ritz, J., Glavin, F., Westervelt, P., Jagasia, M. H., & Chen, Y.-B.
- Venue
- Journal of Clinical Oncology
- Published
- 2017-12-20
- Volume
- 35
- Issue
- 36
- Pages
- 4003-4011
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2766752961
- Cited by
- 323
- References
- 18
- FWCI
- 20.81
- Type
- journal article
- Language
- en
- Open access
- green
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- CoChat. (2026). Citation check: Prospective, Randomized, Double-Blind, Phase III Clinical Trial of Anti–T-Lymphocyte Globulin to Assess Impact on Chronic Graft-Versus-Host Disease–Free Survival in Patients Undergoing HLA-Matched Unrelated Myeloablative Hematopoietic Cell Transplantation. https://app.cochat.ai/papers/10.1200/jco.2017.75.8177
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- Soiffer, R. J., Kim, H. T., McGuirk, J., Horwitz, M. E., Johnston, L., Patnaik, M. M., Rybka, W., Artz, A., Porter, D. L., Shea, T. C., Boyer, M. W., Maziarz, R. T., Shaughnessy, P. J., Gergis, U., Safah, H., Reshef, R., DiPersio, J. F., Stiff, P. J., Vusirikala, M., . . . Chen, Y.-B. (2017). Prospective, Randomized, Double-Blind, Phase III Clinical Trial of Anti–T-Lymphocyte Globulin to Assess Impact on Chronic Graft-Versus-Host Disease–Free Survival in Patients Undergoing HLA-Matched Unrelated Myeloablative Hematopoietic Cell Transplantation. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2017.75.8177
Data sources
Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
