Clinician- and NIH-based responses at 6 months among evaluable subjects compared with the benchmarks. Lower limit of 1-sided 90% CI for both MD- and NIH-defined ORR of 62.5% was 51.5% (Atkinson-Brown estimate), which exceeded benchmark estimate from BMT CTN 0801 (48.6%). Trial MD was the trial clinician–assessed response rate at 6 months; Trial H₀ was the trial null hypothesis based on prior published clinician-assessed 6-month response rates in phase III cGVHD therapy trials; Trial NIH was the trial NIH 6-month response rate; CTN 0801 was the published NIH 6-month response rate in BMT CTN 0801 trial. *Atkinson-Brown 1-sided CI limit was 51.5%.