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Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL (IDEAL2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05082519
Recruitment Status : Recruiting
First Posted : October 19, 2021
Last Update Posted : June 29, 2022
Sponsor:
Collaborator:
Therapeutic Advances in Childhood Leukemia Consortium
Information provided by (Responsible Party):
Etan Orgel, Therapeutic Advances in Childhood Leukemia Consortium

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.


Condition or disease Intervention/treatment Phase
B-cell Acute Lymphoblastic Leukemia Obesity Behavioral: IDEAL2 Intervention Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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).

Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Phase 2 Randomized Trial of Caloric Restriction and Activity to Reduce Chemoresistance in B-cell Acute Lymphoblastic Leukemia
Actual Study Start Date : March 12, 2022
Estimated Primary Completion Date : October 15, 2026
Estimated Study Completion Date : October 15, 2031


Arm Intervention/treatment
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.
Behavioral: IDEAL2 Intervention
Intervention of diet and exercise to improve outcomes for ALL patients

No Intervention: Control - Standard of Care
One-time education of diet and exercise, which is the standard of care for ALL patients during induction.



Primary Outcome Measures :
  1. EOI MRD positivity >= 0.01% [ Time Frame: Prior to day 5 until end of induction (~day 35 from start of chemotherapy) ]
    To compare the rate of MRD >=0.01% at end of induction between experimental arm and control arm

  2. Change in fat mass [ Time Frame: Prior to day 5 until end of induction (~day 35 from start of chemotherapy) ]
    To compare the % change in fat mass from baseline to end of induction between the experimental arm and control arm


Secondary Outcome Measures :
  1. Proportion of patients with >=75% adherence to diet intervention [ Time Frame: Prior to day 5 until end of induction (~day 35 from start of chemotherapy) ]
    To assess the self-reported adherence to the diet component of the IDEAL2 intervention

  2. Proportion of patients with >=75% adherence to exercise intervention [ Time Frame: Prior to day 5 until end of induction (~day 35 from start of chemotherapy) ]
    To assess the self-reported adherence to the exercise component of the IDEAL2 intervention



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Ages Eligible for Study:   10 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05082519


Contacts
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Contact: Ellynore Florendo 323-361-3022 eflorendo@chla.usc.edu
Contact: Roy Leong 323-361-5132 rleong@chla.usc.edu

Locations
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United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Principal Investigator: Etan Orgel, MD         
Children's Hospital Orange County Not yet recruiting
Orange, California, United States, 92868
Principal Investigator: Van Huynh, MD         
UCSF School of Medicine Not yet recruiting
San Francisco, California, United States, 94158
Principal Investigator: Michelle Hermiston, MD         
United States, Georgia
Children's Healthcare of Atlanta at Egleston Not yet recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Melinda Pauly, MD         
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Not yet recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Jenna Rossoff, MD         
United States, Maryland
Johns Hopkins / Sydney Kimmel Cancer Center Not yet recruiting
Baltimore, Maryland, United States, 21231
Principal Investigator: Patrick Brown, MD         
United States, Minnesota
Children's Hospitals and Clinics of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55404
Principal Investigator: Nathan Gossai, MD         
United States, New York
Columbia University Medical Center Not yet recruiting
New York, New York, United States, 10032
Contact: Nobuko Hijiya, MD         
United States, North Carolina
Levine Children's Hospital Not yet recruiting
Charlotte, North Carolina, United States, 28203
Principal Investigator: Joel Kaplan, DO         
United States, Ohio
Cincinnati Children's Hospital Medical Center Not yet recruiting
Cincinnati, Ohio, United States, 45229
Contact: Robin Norris, MD         
Nationwide Children's Hospital Not yet recruiting
Columbus, Ohio, United States, 43205
Principal Investigator: Susan Vear-Colace, MD         
United States, Oregon
Oregon Health & Science University Not yet recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Bill Chang, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Susan Rheingold, MD         
United States, Texas
University of Texas, Southwestern Not yet recruiting
Dallas, Texas, United States, 75235
Contact: Tamra Slone, MD         
Cook Children's Medical Center Not yet recruiting
Fort Worth, Texas, United States, 76104
Principal Investigator: Kenneth Heym, MD         
United States, Wisconsin
Children's Hospital of Wisconsin Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Principal Investigator: Michael Burke, MD         
Sponsors and Collaborators
Etan Orgel
Therapeutic Advances in Childhood Leukemia Consortium
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Responsible Party: Etan Orgel, Principal Investigator, Therapeutic Advances in Childhood Leukemia Consortium
ClinicalTrials.gov Identifier: NCT05082519    
Other Study ID Numbers: T2020-003
First Posted: October 19, 2021    Key Record Dates
Last Update Posted: June 29, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Etan Orgel, Therapeutic Advances in Childhood Leukemia Consortium:
obesity
leukemia
B-cell leukemia
Pediatric obesity
Pediatric ALL
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Obesity
Neoplasms by Histologic Type
Neoplasms
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases