Statistical Analysis
toxicity
The primary end point ‘success of treatment’ was defined as patients receiving six cycles of DB, alive 180 days after end of trial treatment, without progression, and unacceptable toxicity or acute GvHD ≥ grade 3 or extensive chronic GvHD according to Glucksberg or Seattle classification, respectively.Treatment success of ≥50% was considered relevant with a minimum of 35 evaluable patients for assessing efficacy with a Simon's two-stage design (significance level 5%; power 80%),