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RECRUITINGPhase 2INTERVENTIONAL

Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BEHAVIORAL

IDEAL2 Intervention

Intervention of diet and exercise to improve outcomes for ALL patients

Locations (20)

Children's Hospital Los Angeles
Los Angeles, California, United States
Children's Hospital Orange County
Orange, California, United States
UCSF School of Medicine
San Francisco, California, United States
Colorado Children's Hospital
Denver, Colorado, United States
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Johns Hopkins / Sydney Kimmel Cancer Center
Baltimore, Maryland, United States
C.S. Mott University of Michigan
Ann Arbor, Michigan, United States
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States
Columbia University Medical Center
New York, New York, United States
Levine Children's Hospital
Charlotte, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Texas, Southwestern
Dallas, Texas, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Baylor Texas Children's Hospital
Houston, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States