Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL
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.
Conditions:
๐Ÿฆ  B-cell Acute Lymphoblastic Leukemia ๐Ÿฆ  Obesity
๐Ÿ—“๏ธ Study Start (Actual) 12 March 2022
๐Ÿ—“๏ธ Primary Completion (Estimated) 15 October 2026
โœ… Study Completion (Estimated) 15 October 2031
๐Ÿ‘ฅ Enrollment (Estimated) 240
๐Ÿ”ฌ Study Type INTERVENTIONAL
๐Ÿ“Š Phase PHASE2
Locations:
๐Ÿ“ Los Angeles, California, United States
๐Ÿ“ Orange, California, United States
๐Ÿ“ San Francisco, California, United States
๐Ÿ“ Denver, Colorado, United States
๐Ÿ“ Atlanta, Georgia, United States
๐Ÿ“ Chicago, Illinois, United States
๐Ÿ“ Baltimore, Maryland, United States
๐Ÿ“ Ann Arbor, Michigan, United States
๐Ÿ“ Minneapolis, Minnesota, United States
๐Ÿ“ New York, New York, United States
๐Ÿ“ Charlotte, North Carolina, United States
๐Ÿ“ Cincinnati, Ohio, United States
๐Ÿ“ Columbus, Ohio, United States
๐Ÿ“ Portland, Oregon, United States
๐Ÿ“ Philadelphia, Pennsylvania, United States
๐Ÿ“ Dallas, Texas, United States
๐Ÿ“ Fort Worth, Texas, United States
๐Ÿ“ Houston, Texas, United States
๐Ÿ“ Salt Lake City, Utah, United States
๐Ÿ“ Milwaukee, Wisconsin, United States

๐Ÿ“‹ Eligibility Criteria

Description

    Inclusion Criteria:

    • * Patients must be โ‰ฅ 10.0 and \<26.0 years of age.
    • * Patients must have a diagnosis of de novo B-ALL
    • * Patients must have a M3 marrow (\>25% blasts by morphology) or at least 1,000/ยตL 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).
    • * The treatment regimen must be the first treatment attempt for B-ALL-
    • * Must be a multi-agent induction regimen inclusive of vincristine, glucocorticoid, pegaspargase/calaspargase, and daunorubicin or doxorubicin and with a planned duration \<35 days.
    • * Organ function must meet that required for initiation of chemotherapy
    • * Patients at diagnosis must meet Karnofsky \> 50% for patients \> 16 years of age and Lansky \> 50% for patients โ‰ค 16 years of age (or be expected to recover prior to Day 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.

    Exclusion Criteria:

    • * 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).
    • * Patients with Down syndrome or a DNA fragility syndrome (such as Fanconi anemia, Bloom syndrome) will be excluded.
    • * Patient receiving a SJCRH-style "Total Therapy" regimen will be excluded.
    • * Patients receiving anti-CD20 monoclonal antibody therapy during induction therapy.
    • * Patients will be excluded if they received treatment for a previous malignancy.
    • * Patient will be excluded if they are pregnant.
    • * Patient will be excluded if they have a pre-diagnosis requirement for enteral or parenteral supplementation .
    • * Patient will be excluded due to inability to perform the intervention (e.g., specific nutritional needs, severe developmental delay, paraplegia)
    • * 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
Ages Eligible for Study: 10 Years to 25 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

๐Ÿ—“๏ธ 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

  • First Submitted 22 September 2021
  • First Submitted that Met QC Criteria 13 October 2021
  • First Posted 19 October 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 25 October 2023
  • Last Update Posted 26 October 2023
  • Last Verified October 2023