Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268528
Status:
COMPLETED
Last Update Posted:
2020-07-07
First Post:
2005-12-20
Brief Title:
Study to Assess Compliance With Long-Term Mercaptopurine Treatment in Young Patients With Acute Lymphoblastic Leukemia in Remission
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Understanding the Ethnic and Racial Differences in Survival in Children With Acute Lymphoblastic Leukemia
Status:
COMPLETED
Status Verified Date:
2019-10
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:
This clinical trial is assessing compliance with long-term mercaptopurine treatment in young patients with acute lymphoblastic leukemia in remission Assessing why young patients who have acute lymphoblastic leukemia may not take their medications as prescribed may help identify ways to assist them in taking their medications more consistently and may improve long-term treatment outcomes
Detailed Description:
PRIMARY OBJECTIVES
I To determine and compare adherence to maintenance mercaptopurine 6-MP in a cohort of children with acute lymphoblastic leukemia ALL from four different ethnic and racial groups Caucasians African-Americans Hispanics and Asians receiving maintenancecontinuation chemotherapy using the following assessments serial red cell 6-MP metabolites 6-thioguanine 6TGN and methyl thioinosine monophosphate TIMP frequency of 6-MP dosing using an electronic pill monitoring system Microelectromechanical Systems MEMS self-report of adherence to 6-MP by questionnaire
II To determine the impact of adherence to 6-MP measured using 6TGN methyl MeTIMP MEMS and self-report data independently on event-free-survival EFS in the entire cohort after adjusting for known predictors of disease outcome
III Define a critical level of adherence measured independently by 6TGN MeTIMP MEMS self-report that has a significant impact on EFS for the entire cohort
IV Describe prevalence of adherence to 6-MP by ethnicity 6TGN MeTIMP MEMS Self-report
V Describe behavioral and socio-demographic predictors of adherence using the questionnaire data
VI Describe the pill-taking practices in this cohort using the MEMS data VII To evaluate the impact of adherence on ethnicracial difference in EFS
SECONDARY OBJECTIVES
I To assess the concordance among 6TGN and MeTIMP levels electronic pill monitoring and self-reported adherence in the ethnicracial groups
OUTLINE
Patients receive an electronic pill monitoring system comprising an empty MEMS medication bottle with TrackCap child resistant CR The mercaptopurine prescription is filled using this system Beginning on day 1 of the third or later course of maintenance therapy patients take all doses of mercaptopurine from the MEMS medication bottle with TrackCap CR for at least 169 days The MEMS TrackCap CR is mailed to the Coordinating Center at the end of study Patients also receive methotrexate orally PO as indicated by their individual chemotherapy regimen
NOTE Study closed to accrual for Caucasian and Hispanic patients as of 8142009
After completion of study patients are followed up every 6 months for 5 years and then annually for up to 10 years
I To determine and compare adherence to maintenance mercaptopurine 6-MP in a cohort of children with acute lymphoblastic leukemia ALL from four different ethnic and racial groups Caucasians African-Americans Hispanics and Asians receiving maintenancecontinuation chemotherapy using the following assessments serial red cell 6-MP metabolites 6-thioguanine 6TGN and methyl thioinosine monophosphate TIMP frequency of 6-MP dosing using an electronic pill monitoring system Microelectromechanical Systems MEMS self-report of adherence to 6-MP by questionnaire
II To determine the impact of adherence to 6-MP measured using 6TGN methyl MeTIMP MEMS and self-report data independently on event-free-survival EFS in the entire cohort after adjusting for known predictors of disease outcome
III Define a critical level of adherence measured independently by 6TGN MeTIMP MEMS self-report that has a significant impact on EFS for the entire cohort
IV Describe prevalence of adherence to 6-MP by ethnicity 6TGN MeTIMP MEMS Self-report
V Describe behavioral and socio-demographic predictors of adherence using the questionnaire data
VI Describe the pill-taking practices in this cohort using the MEMS data VII To evaluate the impact of adherence on ethnicracial difference in EFS
SECONDARY OBJECTIVES
I To assess the concordance among 6TGN and MeTIMP levels electronic pill monitoring and self-reported adherence in the ethnicracial groups
OUTLINE
Patients receive an electronic pill monitoring system comprising an empty MEMS medication bottle with TrackCap child resistant CR The mercaptopurine prescription is filled using this system Beginning on day 1 of the third or later course of maintenance therapy patients take all doses of mercaptopurine from the MEMS medication bottle with TrackCap CR for at least 169 days The MEMS TrackCap CR is mailed to the Coordinating Center at the end of study Patients also receive methotrexate orally PO as indicated by their individual chemotherapy regimen
NOTE Study closed to accrual for Caucasian and Hispanic patients as of 8142009
After completion of study patients are followed up every 6 months for 5 years and then annually for up to 10 years
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 |
|---|---|---|---|
| NCI-2009-00305 | REGISTRY | None | None |
| CDR0000459748 | None | None | None |
| 07-462 | None | None | None |
| AALL03N1 | OTHER | None | None |
| COG-AALL03N1 | OTHER | None | None |
| AALL03N1 | OTHER | None | None |
| R01CA096670 | NIH | None | None |
| U10CA095861 | NIH | CTEP | httpsreporternihgovquickSearchU10CA095861 |