Summary

Eligibility
for people ages 10-25 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Michelle Hermiston, MD
Headshot of Michelle Hermiston
Michelle Hermiston

Description

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

Details

Keywords

B-cell Acute Lymphoblastic Leukemia, Obesity, leukemia, B-cell leukemia, Pediatric obesity, Pediatric ALL, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoid Leukemia, IDEAL2 Intervention

Eligibility

Locations

  • UCSF School of Medicine accepting new patients
    San Francisco California 94158 United States
  • Children's Hospital Los Angeles accepting new patients
    Los Angeles California 90027 United States

Lead Scientist at UCSF

  • Michelle Hermiston, MD
    Professor Emeritus, Pediatrics, School of Medicine. Authored (or co-authored) 169 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Etan Orgel
ID
NCT05082519
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 240 study participants
Last Updated