A Phase 2 Randomized Trial of Caloric Restriction and Activity to Reduce Chemoresistance in B-cell Acute Lymphoblastic Leukemia
Etan Orgel
Summary
This study is for older children, adolescents, and young adults with B-cell Acute Lymphoblastic Leukemia (B-ALL). Higher amounts of body fat is associated with resistance to chemotherapy in patients with B-ALL. Chemotherapy during the first month causes large gains in body fat in most people, even those who start chemotherapy at a healthy weight. This study is being done to find out if caloric restriction achieved by a personalized nutritional menu and exercise plan during routine chemotherapy can make the patient's ALL more sensitive to chemotherapy and also reduce the amount of body fat gained during treatment. The goals of this study are to help make chemotherapy more effective in treating the patient's leukemia as demonstrated by fewer patients with leukemia minimal residual disease (MRD) while also trying to reduce the amount of body fat that chemotherapy causes the patient to gain in the first month.
Description
GOALS AND OBJECTIVES Hypothesis: Caloric restriction with increased physical activity integrated into induction chemotherapy will decrease chemoresistance and reduce minimal residual disease (MRD). In children receiving induction therapy for NCI/Rome high-risk B-cell acute lymphoblastic leukemia (HR B-ALL), 1.1 Primary Objectives * To examine efficacy of the IDEAL2 (Improving Diet and Exercise in ALL) caloric restriction and activity intervention integrated into HR B-ALL induction to reduce incidence of end of induction (EOI) MRD ≥0.01%. * To examine the efficacy of the IDEAL2 intervention…
Eligibility
- Age range
- 10–25 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must be ≥ 10.0 and \<26.0 years of age. * Patients must have a diagnosis of de novo B-ALL * Patients must have a M3 marrow (\>25% blasts by morphology) or at least 1,000/µL circulating leukemia cells in PB confirmed by Flow Cytometry (or other convincing evidence of a B-ALL diagnosis not meeting above criteria following central review by the Study Hematopathologist and Study Chair or Vice-Chair). * The treatment regimen must be the first treatment attempt for B-ALL- * Must be a multi-agent induction regimen inclusive of vincristine, glucocorticoid, pegaspargase/…
Interventions
- BehavioralIDEAL2 Intervention
Intervention of diet and exercise to improve outcomes for ALL patients
Locations (20)
- Children's Hospital Los AngelesLos Angeles, California
- Children's Hospital Orange CountyOrange, California
- UCSF School of MedicineSan Francisco, California
- Colorado Children's HospitalDenver, Colorado
- Children's Healthcare of Atlanta at EglestonAtlanta, Georgia
- Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, Illinois