Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00317642
Status:
COMPLETED
Last Update Posted:
2014-04-14
First Post:
2006-04-24
Brief Title:
A Study of Clofarabine and Cytarabine for Older Patients With Relapsed or Refractory Acute Myelogenous Leukemia AMLCLASSIC I
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 ie 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
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 ie 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
Detailed Description:
After screening and eligibility assessment patients were randomized in a 11 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 ie 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 Clofarabinecytarabine group and 29 participants in the placebocytarabine group were still being follow-up post treatment Results were reported on clinicaltrialsgov in August 2011 Outcomes that used strata reported the calculated strata on clinicaltrialsgov
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 clinicaltrialsgov AE records on clinicaltrialsgov 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 clinicaltrialsgov 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
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 Clofarabinecytarabine group and 29 participants in the placebocytarabine group were still being follow-up post treatment Results were reported on clinicaltrialsgov in August 2011 Outcomes that used strata reported the calculated strata on clinicaltrialsgov
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 clinicaltrialsgov AE records on clinicaltrialsgov 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 clinicaltrialsgov 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2008-001043-19 | EUDRACT_NUMBER | None | None |