Caloric restriction and exercise to improve chemotherapy effectiveness in B-ALL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on older children, adolescents, and young adults diagnosed with B-cell Acute Lymphoblastic Leukemia (B-ALL) and aims to investigate whether caloric restriction combined with a personalized exercise plan during chemotherapy can enhance the sensitivity of leukemia to treatment. The intervention, known as IDEAL2, seeks to reduce the incidence of minimal residual disease (MRD) and limit the gain of body fat typically associated with chemotherapy. Participants will be monitored for adherence to the dietary and activity components, as well as various clinical outcomes related to their leukemia and overall health.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients must be ≥ 7.0 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/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).
* 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 ≤ 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

Where it's running

• Children's Hospital Los Angeles
  Los Angeles, California, United States Recruiting
• Children's Hospital Orange County
  Orange, California, United States Recruiting
• UCSF School of Medicine
  San Francisco, California, United States Recruiting
• Colorado Children's Hospital
  Denver, Colorado, United States Recruiting
• Ann & Robert H. Lurie Children's Hospital of Chicago
  Chicago, Illinois, United States Recruiting
• Children's Mercy Hospital
  Kansas City, Kansas, United States Recruiting

Study contacts

• Study coordinator: Ellynore Florendo
• Email: eflorendo@chla.usc.edu
• Phone: 323-361-3022

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.