• Robert J Soiffer, Haesook T Kim, Joseph McGuirk, Mitchell E Horwitz, Laura Johnston, Mrinal M Patnaik, Witold Rybka, Andrew Artz, David L Porter, Thomas C Shea, Michael W Boyer, Richard T Maziarz, Paul J Shaughnessy, Usama Gergis, Hana Safah, Ran Reshef, John F DiPersio, Patrick J Stiff, Madhuri Vusirikala, Jeff Szer, Jennifer Holter, James D Levine, Paul J Martin, Joseph A Pidala, Ian D Lewis, Vincent T Ho, Edwin P Alyea, Jerome Ritz, Frank Glavin, Peter Westervelt, Madan H Jagasia, and Yi-Bin Chen.
• Robert J. Soiffer, Haesook T. Kim, Vincent T. Ho, Edwin P. Alyea, and Jerome Ritz, Dana-Farber Cancer Institute; James D. Levine, Beth Israel Deaconess Medical Center and Harvard Medical School; Yi-Bin Chen, Massachusetts General Hospital, Boston; Frank Glavin, Neovii Biotech, Lexington, MA; Joseph McGuirk, University of Kansas Medical Center, Kansas City, KS; Mitchell E. Horwitz, Duke University Medical Center, Durham; Thomas C. Shea, University of North Carolina School of Medicine, Chapel Hill, NC; Laura Johnston, Stanford University, Stanford, CA; Mrinal M. Patnaik, Mayo Clinic, Rochester, MN; Witold Rybka, Penn State College of Medicine, Hershey; David L. Porter, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; Andrew Artz, University of Chicago, Chicago; Patrick J. Stiff, Loyola University Medical Center, Maywood, IL; Michael W. Boyer, University of Utah, Salt Lake City, UT; Richard T. Maziarz, Oregon Health & Science University, Portland, OR; Paul J. Shaughnessy, Texas Transplant Institute, San Antonio; Madhuri Vusirikala, University of Texas Southwestern Medical Center, Dallas, TX; Usama Gergis, Weill Cornell Medical College; Ran Reshef, Columbia University Medical Center, New York, NY; Hana Safah, Tulane University, New Orleans, LA; John F. DiPersio and Peter Westervelt, Washington University School of Medicine, St Louis, MO; Jeff Szer, Royal Melbourne Hospital, Parkville, Victoria; Ian D. Lewis, Royal Adelaide Hospital, Adelaide, South Australia, Australia; Jennifer Holter, University of Oklahoma Health Sciences Center, Oklahoma City, OK; Paul J. Martin, Fred Hutchinson Cancer Research Center, Seattle, WA; Joseph A. Pidala, H. Lee Moffitt Cancer Center, Tampa, FL; and Madan H. Jagasia, Vanderbilt University Medical Center, Nashville, TN.
• J. Clin. Oncol. 2017 Dec 20; 35 (36): 4003-4011.

AbstractPurpose 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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