Improving Diet and Exercise in Acute Lymphoblastic Leukemia (IDEAL Weight in ALL)

In our previous study, we have observed that: 1) nearly half ALL patients are overweight or
obese at diagnosis, 2) all patients, regardless of starting weight, gain significant fat mass
over the first month of therapy (on average 20-30%), and 3) obesity at the time of diagnosis
is associated with a higher likelihood of poor response to chemotherapy as evidenced by
persistent leukemia (minimal residual disease) after induction therapy. Together, these data
show that body fat is a significant risk factor for ALL treatment failure, and that its
negative effects are evident within the first month of treatment. Recent laboratory and
clinical data illustrates the ability of diet restriction and physical activity to improve
chemotherapy efficacy, reduce treatment-related toxicities and better overall quality of
life.

Given the importance of successful induction therapy for ALL in predicting long term survival
and the negative role of obesity on treatment success, this study tests a complete
personalized dietary and exercise intervention for pre-adolescents, adolescents, and young
adults newly diagnosed with B-precursor ALL ("pre-B ALL") that aims to reduce fat gained
during induction therapy and thereby improve treatment response, toxicity rates, and quality
of life.

Inclusion Criteria:

- Greater than or equal to 10 years of age and less than or equal to 21 years of age at
time of diagnosis

- Have a new diagnosis of untreated NCI/Rome High Risk B-precursor ALL (HR-ALL)

- Are beginning treatment on- or as per- a CCG-COG protocol with a 4-drug Induction
including vincristine, daunorubicin (or doxorubicin), asparaginase, and at least 14
days of glucocorticoid steroids

Exclusion Criteria:

- Have a diagnosis of Down syndrome (Trisomy 21) or any genetic disease associated with
abnormal body composition

- Be underweight or "at risk for underweight" with moderate weight loss, defined as a
starting Body Mass Index (BMI) <10th percentile for age and sex (for those >20 years
of age, defined as an absolute BMI < 18.5)

- Have pre-existing abnormal intestinal function (e.g. protein-wasting enteropathy, fat
malabsorption)

- Be unable to comply with the recommended diet or activity interventions (as determined
by study or treatment team)

- Have a history of prior chemotherapy or radiation for other cancers

- Be unable to complete the necessary radiology examinations with fully interpretable
data (e.g. hip replacement and metal prostheses preclude evaluation by DXA)

- Be pregnant (to be confirmed by urine or serum pregnancy test as per institutional
routine care for chemotherapy and radiology exams)