Efficacy and Safety Study of MDV9300 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Duration of response (for responders)

Defined as the time from the first objective evidence of CR or PR as assessed by the IRC to the first objective evidence of disease progression or death due to any cause, whichever occurs first.

Time frame: no later than 6 months after the last patient is enrolled in a cohort

Progression-free survival

Defined as the time from the date of first study drug infusion to the first objective evidence of disease progression or death due to any cause, whichever occurs first.

Time frame: no later than 6 months after the last patient is enrolled in a cohort

Time to response (for responders)

Defined as the time from the date of first study drug infusion to the first objective evidence of CR or PR as assessed by the IRC.

Time frame: no later than 6 months after the last patient is enrolled in a cohort

Overall survival

Defined as the time from the date of first study drug infusion to death due to any cause.

Time frame: no later than 6 months after the last patient is enrolled in a cohort

Composite of safety

Safety will be evaluated by incidence and severity of adverse events, including serious adverse events and incidence of permanent treatment discontinuation due to adverse events.