Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma

Arms (2)

1. type

   ACTIVE_COMPARATOR

   label

   temsirolimus (Torisel) 175mg weekly x 3, then 75mg weekly

   interventionNames

   1. Drug: temsirolimus

2. type

   ACTIVE_COMPARATOR

   label

   temsirolimus (Torisel) 75mg weekly

   interventionNames

   1. Drug: temsirolimus

Primary outcomes (1)

1. measure

   Independently Assessed Progression-free Survival (PFS)

   timeFrame

   From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)

   description

   PFS is defined as the time from randomization to first documentation of disease progression by the independent assessor or to death due to any cause, whichever occurred first. PFS = (earliest date of progression or death due to any cause- randomization date+1)/30.4. PFS assessment was done using EMA guidelines for sensitivity analysis censoring. Participants who were alive and progression-free at the time of analysis were censored on the date of last assessment; participants without adequate baseline assessment or without post-baseline assessments were censored on the randomization date; participants who died or progressed after 2 or more missed visits were censored on the date of last tumor assessment prior to the missing visit; and participants who started new anti-cancer therapy prior to death or progression were censored on the date of last tumor assessment prior to the start of anti-tumor treatment.