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RECRUITING
NCT05082519
PHASE2

Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL

Sponsor: Etan Orgel

View on ClinicalTrials.gov

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

BEHAVIORAL

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