Acute Myelogenous Leukemia Clinical Trial
Official title:
A Phase III Randomized, Double-blind, Controlled Study Comparing Clofarabine and Cytarabine Versus Cytarabine Alone in Adult Patients 55 Years and Older With Acute Myelogenous Leukemia (AML) Who Have Relapsed or Are Refractory After Receiving up to Two Prior Induction Regimens
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the
treatment of pediatric patients 1 to 21 years old with relapsed acute or refractory
lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.
There is no recommended standard treatment for relapsed or refractory acute myelogenous
leukemia in older patients. Cytarabine is the most commonly used drug to treat these
patients. This study will determine if there is benefit by combining clofarabine with
cytarabine. Patients will be randomized to receive up to 3 cycles of treatment with either
placebo in combination with cytarabine or clofarabine in combination with cytarabine.
Randomization was stratified by remission status following the first induction regimen (no
remission [i.e., CR1 = refractory] or remission <6 months vs CR1 = remission ≥6 months). CR1
is defined as remission after first pre-study induction regimen. The safety and tolerability
of clofarabine in combination with cytarabine and cytarabine alone will be monitored
throughout the study.
After screening and eligibility assessment, patients were randomized (in a 1:1 ratio) to
receive either clofarabine or matching placebo, in addition to cytarabine. Randomization was
stratified by remission status following the first induction regimen (CR1): no remission
[i.e., CR1 = refractory] or remission <6 months vs remission ≥6 months. During randomization
by interactive voice response system (IVRS), there were 10 participants misclassified to the
CR1 <6 months stratum and 12 participants misclassified to CR1 ≥6 months stratum. The error
did not affect the participants' treatment, only the stratification. Due to the
misclassification, outcomes that used strata in their analysis were analyzed twice: once
with the 'randomized stratification' which includes the misclassification and once with the
'calculated stratification' in which participants appear in the 'correct' strata.
Two clinical study reports were written for this study.
1. Clinical study report dated 7 April 2011 includes the entire treatment period of all
participants plus much of the follow-up. At that time, 33 participants in the
Clofarabine+cytarabine group and 29 participants in the placebo+cytarabine group were
still being follow-up post treatment. Results were reported on clinicaltrials.gov in
August 2011. Outcomes that used strata reported the 'calculated strata' on
clinicaltrials.gov.
2. Clinical study report dated 9 July 2012 includes all patient treatment experience plus
all long-term follow-up (a minimum of 2 years from the end of treatment or until the
patient died). The study was completed at that time. Outcomes that used strata reported
the 'randomized strata' on clinicaltrials.gov. AE records on clinicaltrials.gov reflect
the final database.
Outcomes that changed between the two clinical study reports due to the additional long-term
follow-up data are reported twice on clinicaltrials.gov (once from each clinical study
report) and the appropriate report date is included in the outcome description. Outcomes
from the 9 July 2012 report represent more complete data.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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