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Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL
Sponsor: 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.
Official title: A Phase 2 Randomized Trial of Caloric Restriction and Activity to Reduce Chemoresistance in B-cell Acute Lymphoblastic Leukemia
Key Details
Gender
All
Age Range
10 Years - 25 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2022-03-12
Completion Date
2031-10-15
Last Updated
2023-10-26
Healthy Volunteers
No
Interventions
IDEAL2 Intervention
Intervention of diet and exercise to improve outcomes for ALL patients
Locations (20)
Children's Hospital Los Angeles
Los Angeles, California, United States
Children's Hospital Orange County
Orange, California, United States
UCSF School of Medicine
San Francisco, California, United States
Colorado Children's Hospital
Denver, Colorado, United States
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Johns Hopkins / Sydney Kimmel Cancer Center
Baltimore, Maryland, United States
C.S. Mott University of Michigan
Ann Arbor, Michigan, United States
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States
Columbia University Medical Center
New York, New York, United States
Levine Children's Hospital
Charlotte, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Texas, Southwestern
Dallas, Texas, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Baylor Texas Children's Hospital
Houston, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States