Title (COG AALL03N1) Understanding the Role of Adherence and Ethnic Differences in Survival After Childhood ALL
Principal Investigator Green
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.
- 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).