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Recruiting Phase 2 Interventional

Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL

ClinicalTrials.gov ID: NCT05082519

Public ClinicalTrials.gov record NCT05082519. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 5:33 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05082519
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Etan Orgel
Other
Enrollment
240 participants

Conditions and interventions

Interventions

Behavioral

Eligibility (public fields only)

Age range
7 Years to 25 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 11, 2022
Primary completion
Aug 14, 2027
Completion
Aug 14, 2032
Last update posted
Aug 18, 2026

2022 – 2032

United States locations

U.S. sites
16
U.S. states
13
U.S. cities
16
Facility City State ZIP Site status
Children's Hospital Los Angeles Los Angeles California 90027 Recruiting
Children's Hospital Orange County Orange California 92868 Recruiting
UCSF School of Medicine San Francisco California 94158 Recruiting
Colorado Children's Hospital Denver Colorado 80045 Recruiting
Children's Healthcare of Atlanta at Egleston Atlanta Georgia 30322 Not yet recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois 60611 Recruiting
Children's Mercy Hospital Kansas City Kansas 64108 Recruiting
C.S. Mott University of Michigan Ann Arbor Michigan 48109 Recruiting
Children's Hospitals and Clinics of Minnesota Minneapolis Minnesota 55404 Recruiting
Levine Children's Hospital Charlotte North Carolina 28203 Recruiting
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 Recruiting
Oregon Health & Science University Portland Oregon 97239 Recruiting
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 Recruiting
University of Texas, Southwestern Dallas Texas 75235 Recruiting
Baylor Texas Children's Hospital Houston Texas 77030 Recruiting
Primary Children's Hospital Salt Lake City Utah 84113 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05082519, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 18, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05082519 live on ClinicalTrials.gov.

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