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

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

Phase 2 Interventional Therapeutic Advances in Childhood Leukemia Consortium · NCT05082519

This study is testing if eating less and following a personalized exercise plan during chemotherapy can help older kids and young adults with B-cell Acute Lymphoblastic Leukemia respond better to treatment and avoid gaining weight.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment240 (estimated)
Ages10 Years to 25 Years
SexAll
SponsorTherapeutic Advances in Childhood Leukemia Consortium Academic / other
Drugs / interventionschemotherapy, doxorubicin, immunotherapy
Locations20 sites (Los Angeles, California and 19 other locations)
Trial IDNCT05082519 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 10 to 25 years with a diagnosis of de novo B-ALL who are beginning their first treatment regimen.

Not a fit: Patients who are not starting their first treatment for B-ALL or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective chemotherapy treatment for B-ALL patients and help manage weight gain during treatment.

How similar studies have performed: While the specific combination of caloric restriction and exercise during chemotherapy for B-ALL is novel, similar approaches in other cancers have shown promising results.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Patients must be ≥ 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/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 this trial is running

Los Angeles, California and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions B-cell Acute Lymphoblastic LeukemiaObesityobesityleukemiaB-cell leukemiaPediatric obesityPediatric ALL
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.