Grants and Contracts Details
SUBCONTRACTEE will perform MRIs of the hips and knees of patients enrolled in COG study AALL1131. Further details are provided below. Study Objectives, Design, and Accrual The primary objective is to determine the overall incidence and pattern of joint involvement of ON according to stage and age. The study will estimate the proportion of patients in each age group that develop ON by MRI, and also determine the distribution of stage (0, 1, 2, 3, 4) within each age group. Given the estimated sample sizes in each age group, the incidence of ON can be estimated in each age group with a maximum standard error of 5.5% in the smallest group (16 years old and older). The primary aims are: (1) to determine the incidence of radiologic ON according to stage and patient age; (2) to determine the incidence of radiologic progression of disease; (3) to determine the incidence of clinical progression of disease; and (4) to identify factors that are predictive of radiologic and clinical progression. Study Design: MRIs will be completed in 300 patients at three time points per patient. These studies will be focused MRIs of the hips and knees in the coronal plane only. All imaging studies will be centrally reviewed at Quality Associated Review Center (QARC) and the extent of epiphyseal involvement will be graded as detailed in the concept. MRIs will be obtained at the following time points during therapy in children and young adults 10 years of age or older at the time of AALL1131 enrollment: • End of Consolidation • Beginning of Maintenance • End of therapy These time points were chosen to determine the impact of different phases of therapy where drugs known and suspected to be associated with ON (i.e. corticosteroids, methotrexate and asparaginase) are administered. The first time point, end of consolidation, will assess the impact of corticosteroid administration during induction as well as other agents during consolidation. The second time point (beginning of maintenance) will assess corticosteroid exposure during delayed intensification (DI) as well as other agents during interim maintenance and DI. The final time point (end of therapy) will assess corticosteroid exposure during maintenance pulses. This correlative study is embedded within the larger therapeutic study. Consent for this study will be incorporated into the consent for enrollment of High-risk High ALL and High-risk Average ALL patients into their respective arms of the parent study. Patients who enroll in AALL1131 and meet the eligibility requirements listed above may elect to enroll on this ancillary study as an option, not a requirement. Children and young adults may have MRIs performed at their local institutions as standard of care for evaluation of joint pain/suspected ON at different times during therapy and these MRIs can be used in addition to the above screening MRIs to stage lesions. However, the screening MRIs on this study will still be completed at the three designated time points, even if additional studies are performed at different times for clinical indications. Entire study population: A total of 300 patients will be accrued from member institutions who choose to participate in this study. Based on age distribution on past ALL trials, it is projected that 105 pts will be 10-12 years of age, 110 will be 13-15 years old, and 85 will be 16+ years old at diagnosis.
|Effective start/end date||3/1/16 → 1/12/24|
- Public Health Institute: $2.00
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