RECRUITING

Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2022-03-12
Study Completion:2031-10-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05082519

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients must be ≥ 10.0 and \<26.0 years of age.
  2. * Patients must have a diagnosis of de novo B-ALL
  3. * Patients must have a M3 marrow (\>25% blasts by morphology) or at least 1,000/µL circulating leukemia cells in PB confirmed by Flow Cytometry (or other convincing evidence of a B-ALL diagnosis not meeting above criteria following central review by the Study Hematopathologist and Study Chair or Vice-Chair).
  4. * The treatment regimen must be the first treatment attempt for B-ALL-
  5. * Must be a multi-agent induction regimen inclusive of vincristine, glucocorticoid, pegaspargase/calaspargase, and daunorubicin or doxorubicin and with a planned duration \<35 days.
  6. * Organ function must meet that required for initiation of chemotherapy
  7. * Patients at diagnosis must meet Karnofsky \> 50% for patients \> 16 years of age and Lansky \> 50% for patients ≤ 16 years of age (or be expected to recover prior to Day 8) .
  8. * If the patient is a female of childbearing potential, a negative urine or serum pregnancy test is required within two weeks prior to enrollment.
  1. * Patient will be excluded if they are underweight at time of enrollment (BMI% \<5th percentile for age for patients age 10-19 years, BMI \<18.5 in patients 20-29 years).
  2. * Patients with Down syndrome or a DNA fragility syndrome (such as Fanconi anemia, Bloom syndrome) will be excluded.
  3. * Patient receiving a SJCRH-style "Total Therapy" regimen will be excluded.
  4. * Patients receiving anti-CD20 monoclonal antibody therapy during induction therapy.
  5. * Patients will be excluded if they received treatment for a previous malignancy.
  6. * Patient will be excluded if they are pregnant.
  7. * Patient will be excluded if they have a pre-diagnosis requirement for enteral or parenteral supplementation .
  8. * Patient will be excluded due to inability to perform the intervention (e.g., specific nutritional needs, severe developmental delay, paraplegia)
  9. * Patients will be excluded if they have significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with the protocol treatment or procedures, interfere with consent, study participation, follow up, or interpretation of study results

Contacts and Locations

Study Contact

Ellynore Florendo
CONTACT
323-361-3022
eflorendo@chla.usc.edu
Roy Leong
CONTACT
323-361-5132
rleong@chla.usc.edu

Study Locations (Sites)

Children's Hospital Los Angeles
Los Angeles, California, 90027
United States
Children's Hospital Orange County
Orange, California, 92868
United States
UCSF School of Medicine
San Francisco, California, 94158
United States
Colorado Children's Hospital
Denver, Colorado, 80045
United States
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States
Johns Hopkins / Sydney Kimmel Cancer Center
Baltimore, Maryland, 21231
United States
C.S. Mott University of Michigan
Ann Arbor, Michigan, 48109
United States
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404
United States
Columbia University Medical Center
New York, New York, 10032
United States
Levine Children's Hospital
Charlotte, North Carolina, 28203
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
University of Texas, Southwestern
Dallas, Texas, 75235
United States
Cook Children's Medical Center
Fort Worth, Texas, 76104
United States
Baylor Texas Children's Hospital
Houston, Texas, 77030
United States
Primary Children's Hospital
Salt Lake City, Utah, 84113
United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Etan Orgel

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-12
Study Completion Date2031-10-15

Study Record Updates

Study Start Date2022-03-12
Study Completion Date2031-10-15

Terms related to this study

Keywords Provided by Researchers

  • obesity
  • leukemia
  • B-cell leukemia
  • Pediatric obesity
  • Pediatric ALL

Additional Relevant MeSH Terms

  • B-cell Acute Lymphoblastic Leukemia
  • Obesity