Major finding: The median time to treatment failure
, a composite endpoint including arrest/incarceration or psychiatric hospitalization, was 416 days in patients randomized to paliperidone palmitate and 226 days in those assigned to an oral antipsychotic.
The study design required 52 eligible patients to detect a 50% improvement in the median time to treatment failure
(TTF) compared with that reported for six cycles of RCHOP.
For patients who did not receive rituximab induction, maintenance therapy was associated with increased time to treatment failure
, but not in overall survival in the primary analysis.
EndPoints n=62 n=67 placebo Time to Treatment Failure
at Study Day 50 (primary endpoint) n/a n/a 0.
8% partial response) with a median time to treatment failure
of seven months.
The primary endpoint of the study is a comparison of the two treatment arms of the median time to treatment failure
, defined as the need for additional therapies due to uncontrolled signs or symptoms of GvHD.
Secondary endpoints are duration of complete remission, time to treatment failure
, survival at 12 months, 30, 60, and 90 day mortality and safety and tolerability.
Time to treatment failure
, with treatment failure defined as vomiting or use of rescue medication, was significantly longer for patients treated with Aloxi compared to patients receiving ondansetron or dolasetron.
Secondary endpoints include progression-free survival, time to progression, time to treatment failure
, time to response, duration of response and overall survival.
During a pre-planned interim analysis of the study data conducted by an independent ECOG Data Monitoring Committee (DMC), the data showed a statistically significant improvement in time to treatment failure
(TTF) for patients who received Rituxan maintenance therapy.
Secondary endpoints include a comparison of response rate between the dose groups, progression-free survival, time to treatment failure
and overall survival.
For the analysis of the primary endpoint of the induction phase of the study -- time to treatment failure
(TTF) -- patients who received R-CHOP chemotherapy followed by Rituxan maintenance therapy or observation demonstrated a trend toward prolongation of TTF, as compared to patients who received CHOP alone followed by Rituxan maintenance therapy or observation.