Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL

Part of paid clinical trials in Los Angeles, California.

Sponsor
Etan Orgel
Study ID
NCT05082519
Phase
PHASE2
Status
Recruiting
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Conditions

  • B-cell Acute Lymphoblastic Leukemia
  • Obesity

Eligibility Criteria

Sex
ALL
Age
10 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • IDEAL2 Intervention — BEHAVIORAL
    Intervention of diet and exercise to improve outcomes for ALL patients

Study Details

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.

Key Dates

Start date
Mar 12, 2022
Status verified
Oct 2023
Primary completion
Oct 15, 2026
Completion
Oct 15, 2031

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

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

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027
Etan Orgel, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital Orange CountyOrangeCalifornia92868
Van Huynh, MD (PRINCIPAL_INVESTIGATOR)
UCSF School of MedicineSan FranciscoCalifornia94158
Michelle Hermiston, MD (PRINCIPAL_INVESTIGATOR)
Colorado Children's HospitalDenverColorado80045
Lisa Hartman, M.D.
Children's Healthcare of Atlanta at EglestonAtlantaGeorgia30322
Melinda Pauly, MD (PRINCIPAL_INVESTIGATOR)
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611
Jenna Rossoff, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins / Sydney Kimmel Cancer CenterBaltimoreMaryland21231
Patrick Brown, MD (PRINCIPAL_INVESTIGATOR)
C.S. Mott University of MichiganAnn ArborMichigan48109
Jennifer Agrusa, M.D.
Children's Hospitals and Clinics of MinnesotaMinneapolisMinnesota55404
Nathan Gossai, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Medical CenterNew YorkNew York10032
Nobuko Hijiya, MD
Levine Children's HospitalCharlotteNorth Carolina28203
Joel Kaplan, DO (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Robin Norris, MD
Nationwide Children's HospitalColumbusOhio43205
Susan Vear-Colace, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health & Science UniversityPortlandOregon97239
Bill Chang, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Susan Rheingold, MD (PRINCIPAL_INVESTIGATOR)
University of Texas, SouthwesternDallasTexas75235
Tamra Slone, MD
Cook Children's Medical CenterFort WorthTexas76104
Kenneth Heym, MD (PRINCIPAL_INVESTIGATOR)
Baylor Texas Children's HospitalHoustonTexas77030
Karen Rabin, M.D.
Primary Children's HospitalSalt Lake CityUtah84113
Mallorie Heneghan, M.D.
Children's Hospital of WisconsinMilwaukeeWisconsin53226
Michael Burke, MD (PRINCIPAL_INVESTIGATOR)

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Children's Hospital Los Angeles· Los Angeles, CAChildren's Hospital Orange County· Orange, CAUCSF School of Medicine· San Francisco, CAColorado Children's Hospital· Denver, COChildren's Healthcare of Atlanta at Egleston· Atlanta, GAAnn & Robert H. Lurie Children's Hospital of Chicago· Chicago, IL

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