Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL

NCT05082519 | Recruiting Phase 2 DMC

• 1 other identifier: T2020-003
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 20

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

Keywords

obesity; leukemia; B-cell leukemia; Pediatric obesity; Pediatric ALL

Outcome Measures

Primary Outcomes (2)

• EOI MRD positivity >= 0.01%

  To compare the rate of MRD \>=0.01% at end of induction between experimental arm and control arm

  Prior to day 5 until end of induction (~day 35 from start of chemotherapy)

• Change in fat mass

  To compare the % change in fat mass from baseline to end of induction between the experimental arm and control arm

  Prior to day 5 until end of induction (~day 35 from start of chemotherapy)

Secondary Outcomes (2)

• Proportion of patients with >=75% adherence to diet intervention

  Prior to day 5 until end of induction (~day 35 from start of chemotherapy)

• Proportion of patients with >=75% adherence to exercise intervention

  Prior to day 5 until end of induction (~day 35 from start of chemotherapy)

Study Arms (2)

IDEAL2 intervention

EXPERIMENTAL

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.

Behavioral: IDEAL2 Intervention

Control - Standard of Care

NO INTERVENTION

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

Interventions

IDEAL2 Intervention BEHAVIORAL

Intervention of diet and exercise to improve outcomes for ALL patients

IDEAL2 intervention

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Etan Orgel: lead
• Therapeutic Advances in Childhood Leukemia Consortium: collaborator

Study Sites (20)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

Children's Hospital Orange County

Orange, California, 92868, United States

RECRUITING

UCSF School of Medicine

San Francisco, California, 94158, United States

RECRUITING

Colorado Children's Hospital

Denver, Colorado, 80045, United States

RECRUITING

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, 30322, United States

NOT YET RECRUITING

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

Chicago, Illinois, 60611, United States

RECRUITING

Johns Hopkins / Sydney Kimmel Cancer Center

Baltimore, Maryland, 21231, United States

NOT YET RECRUITING

C.S. Mott University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10032, United States

NOT YET RECRUITING

Levine Children's Hospital

Charlotte, North Carolina, 28203, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

NOT YET RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

NOT YET RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

NOT YET RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Texas, Southwestern

Dallas, Texas, 75235, United States

RECRUITING

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

NOT YET RECRUITING

Baylor Texas Children's Hospital

Houston, Texas, 77030, United States

RECRUITING

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

RECRUITING

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma; Obesity; Leukemia; Leukemia, B-Cell; Pediatric Obesity; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Leukemia, Lymphoid

Central Study Contacts

Ellynore Florendo

CONTACT

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

Roy Leong

CONTACT

323-361-5132; rleong@chla.usc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a randomized Phase 2 study in patients with HR B-ALL comparing the efficacy of one-time education + the IDEAL2 intervention (experimental) versus one-time education alone (control) in reducing the rate (probability) of having detectable minimum residual disease at the end of induction therapy (EOI MRD) and in reducing the amount of fat gained during induction. Eligible patients will be randomized 1:1 to either the experimental or control arms using stratified, blocked randomization within four strata defined by presenting WBC (\< 50K/uL, ≥ 50K/uL) and body mass index (normal weight vs overweight/obese).

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 19, 2021
• Study Start: March 12, 2022
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2031
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

US (20)