Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Study of the Efficacy and Safety of Vosaroxin and Cytarabine Versus Placebo and Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia (VALOR)
This study compared treatment groups of patients treated with vosaroxin and cytarabine versus patients treated with placebo and cytarabine.
The study includes additional objectives to ones listed above as Outcome Measures. These
additional objectives also compared treatment groups in the following:
CR + CRp rate, defined as CR + CRp based on modified IWG response criteria.
Combined CR rate (CR+CRp+CRi).
Percentage of patients who have post-treatment (subsequent) transplantation.
Percentage of patients who received subsequent non-protocol therapy (including
transplantation).
Safety and tolerability.
In keeping with FDA guidance for adaptive trial designs, the study incorporated an
independent DSMB (Drug Safety Monitoring Board) to address potential uncertainty concerning
the true treatment affect between the treatment groups and to address a deterioration of
power from a small difference. Sunesis remained blinded and had no involvement in the interim
data analysis, interpretation, or adaptive design. Based on the results of the interim data
analysis the DSMB recommended an increase in the target number of deaths from 375 in 450
patients to 562 in 675 patients which based on a 5% dropout rate increased enrollment from
475 to 712.
The primary analysis was performed when the target number of deaths had been achieved based
on a permuted block randomization procedure, stratified by disease status (refractory, first
relapse with duration of first CR or CRp ≥ 90 days and < 12 months, or first relapse with
duration of first CR or CRp ≥ 12 months and ≤ 24 months), age (< 60 years or ≥ 60 years), and
geographic location (US or outside US). The study included periods of screening, treatment /
hematologic recovery, post-treatment follow-up, and long-term follow-up for survival.
Follow-up was monthly during the first year, every 2 months during the second year, and every
3 months thereafter until death, withdrawal of consent, or loss to follow-up, whichever
occurred first. Long-term follow-up began for all patients when the required number of deaths
for primary analysis had been met; thereafter, survival data were collected every 4 months
until death, withdrawal of consent, or loss to follow-up, whichever occurred first.
The long term follow-up for this study continues at this time and the September 2014 date
reflects database lock for primary analyses reflected in the Results Section. During long
term follow-up Sunesis is not collecting Adverse Events.
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