RecruitingPhase 2NCT05082519

Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL

A Phase 2 Randomized Trial of Caloric Restriction and Activity to Reduce Chemoresistance in B-cell Acute Lymphoblastic Leukemia


Sponsor

Etan Orgel

Enrollment

240 participants

Start Date

Mar 12, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 10 YearsMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether caloric restriction (eating less) and exercise during the first phase of chemotherapy can reduce resistance to treatment in children and young adults with newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL), a type of blood cancer. **You may be eligible if...** - You are 10–25 years old - You have a new diagnosis of B-cell acute lymphoblastic leukemia (B-ALL) - Your bone marrow shows more than 25% leukemia cells (M3 marrow) or high circulating leukemia cells - You are starting your first-ever treatment for this leukemia - Your organs are healthy enough for chemotherapy - You are not underweight at the time of enrollment **You may NOT be eligible if...** - You are underweight (BMI below the 5th percentile for children; BMI < 18.5 for young adults) - You have Down syndrome or a DNA fragility syndrome (Fanconi anemia, Bloom syndrome) - You are receiving a specific high-intensity chemotherapy regimen Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALIDEAL2 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05082519


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