(COG AALL03N1) Understanding the Role of Adherence and Ethnic Differences in Survival After Childhood ALL
Title (COG AALL03N1) Understanding the Role of Adherence and Ethnic Differences in Survival After Childhood ALL
Contact N/A
Principal Investigator Green
PhaseN/A
Summary This is a non-therapeutic study with an overall goal to conduct a comprehensive study across ethnic groups to elucidate the reasons for the observed differences in survival by race and ethnicity, thus building a framework for appropriate interventions to address this problem in the future. There are Ethnic/racial differences in systemic exposure to 6-MP in a cohort of children with ALL from four different ethnic and racial groups (Caucasians, African American, Hispanics, Asians) receiving maintenance chemotherapy. Adherence will be assessed by measuring red cell 6-MP metabolites, frequency of 6-MP dosing using an electronic pill monitoring system, and self report of adherence to 6-MP.
Eligibility
- Diagnosis of ALL at less than or equal to 21 years of age, in first remission, irrespective of risk stratification. Enrollment on a COG therapeutic study for ALL is not required, but the treatment plan must meet the criteria outlined in section 3.1.3
- Belongning to one of the four following ethnic/racial categories: African American, Asian, Caucasian, or Hispanic.
- Receiving self or parent/caregiver administered oral anti-metabolite chemotherapy during the maintenance phase of therapy. Patients are eligible if their treatment plan calls for the following doses 6-MP and MTX during maintenance phase: 6-MP 75mg/m2/d orally; MTX 20mg/m2/wk orally.
- Has completed at least two courses of maintenance chemotherapy, and is scheduled to receive at least two more planned course of maintenance chemotherapy. (Note: a course is defined as 12 wks/84 d maintenance chemotherpy).
