Recruiting
Phase 2

Caloric Restriction & Activity

Sponsor:

Etan Orgel

Code:

NCT05082519

Conditions

B-cell Acute Lymphoblastic Leukemia

Obesity

Eligibility Criteria

Sex: All

Age: 7 - 25

Healthy Volunteers: Not accepted

Interventions

IDEAL2 Intervention

Study Details

Brief 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.

Conditions

B-cell Acute Lymphoblastic Leukemia

Obesity

Study ID

NCT05082519

Start date

Mar 12, 2022

Status verified date

Aug, 2026

Completion date

Aug 15, 2032

Anticipated

Primary completion date

Aug 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 25

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: IDEAL2 intervention

Focused and short-term intervention of diet and exercise during induction. Calorie goal is >=15% daily deficit as determined by each subject's estimated energy requirement. Fat intake will make up <25% of daily calories. Carbohydrate will make up <55% of daily calories consisting of "low" glycemic load foods (<100/2,000 kcal adjusted for daily calories). Protein will make up >=20% of daily calories. Subjects will also perform moderate exercise 5 days per week for 30 minutes/session (total = 150 minutes per week). Subjects will have a step goal to decrease sedentary behavior, with a starting goal of >=1000 steps/day and increasing by at least 1000 steps/day each week.

no intervention: Control - Standard of Care

One-time education of diet and exercise, which is the standard of care for ALL patients during induction.

Interventions

IDEAL2 Intervention

Intervention of diet and exercise to improve outcomes for ALL patients

Primary outcome measure

  • EOI MRD positivity >= 0.01% [ Time Frame: Prior to day 5 until end of induction (~day 35 from start of chemotherapy) ]
  • Change in fat mass [ Time Frame: Prior to day 5 until end of induction (~day 35 from start of chemotherapy) ]

Central Contacts and Locations

Central contacts

Ellynore Florendo

323-361-3022eflorendo@chla.usc.edu

Suganya Rajendran

323-361-8835srajendran@chla.usc.edu

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Principal Investigator:

Etan Orgel, MD

Children's Hospital Orange County

Recruiting

Orange, California, United States, 92868

Principal Investigator:

Van Huynh, MD

UCSF School of Medicine

Recruiting

San Francisco, California, United States, 94158

Principal Investigator:

Michelle Hermiston, MD

Colorado Children's Hospital

Recruiting

Denver, Colorado, United States, 80045

Ann & Robert H. Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

Jenna Rossoff, MD

Children's Mercy Hospital

Recruiting

Kansas City, Kansas, United States, 64108

C.S. Mott University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Children's Hospitals and Clinics of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55404

Principal Investigator:

Nathan Gossai, MD

Levine Children's Hospital

Recruiting

Charlotte, North Carolina, United States, 28203

Principal Investigator:

Joel Kaplan, DO

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Principal Investigator:

Bill Chang, MD

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Susan Rheingold, MD

University of Texas, Southwestern

Recruiting

Dallas, Texas, United States, 75235

Baylor Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Primary Children's Hospital

Recruiting

Salt Lake City, Utah, United States, 84113

More Information

Sponsor

Etan Orgel

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Etan Orgel on 2026-08-19.