RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
7 Years to 25 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for people ages 7 to 25 with newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL), a blood cancer. It tests whether a personal meal plan with fewer calories and an exercise plan during regular chemotherapy can help the treatment work better and limit body fat gain in the first month.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 7 to 25.
  • Have newly diagnosed B-ALL.
  • Have more than 25% leukemia cells in the bone marrow, at least 1,000 leukemia cells per microliter of blood confirmed by testing, or other proof approved by the study experts.
  • Be starting the first treatment for B-ALL.
  • Have a first round of chemotherapy planned to last less than 35 days, using vincristine, a steroid, pegaspargase or calaspargase, and daunorubicin or doxorubicin.
  • Have organs that work well enough to start chemotherapy.
  • Have a score above 50 on an age-based scale of daily activity, or be expected to reach this level before Day 8.
  • If able to become pregnant, have a negative urine or blood pregnancy test within two weeks before joining.

Who can't join

  • Be underweight when joining: below the 5th percentile for body mass index (BMI) at ages 10–19, or BMI below 18.5 at ages 20–29.
  • Have Down syndrome or a condition that makes DNA break easily, such as Fanconi anemia or Bloom syndrome.
  • Receive an SJCRH-style “Total Therapy” plan or anti-CD20 antibody treatment during the first round of chemotherapy.
  • Have been treated for another cancer.
  • Be pregnant.
  • Have needed extra nutrition through a feeding tube or vein before diagnosis.
  • Be unable to follow the meal or exercise plan because of needs such as a special diet, severe developmental delay, or paralysis of the legs.
  • Have another illness, mental health condition, or social problem that could affect safety, consent, study participation, follow-up, or study results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (16)

CA

CO

GA

  • Children's Healthcare of Atlanta at Egleston · Atlanta, GA 30322Melinda Pauly, MD · Principal investigatorMore trials in Atlanta

IL

  • Ann & Robert H. Lurie Children's Hospital of Chicago · Chicago, IL 60611Jenna Rossoff, MD · Principal investigatorMore trials in Chicago

KS

MI

MN

  • Children's Hospitals and Clinics of Minnesota · Minneapolis, MN 55404Nathan Gossai, MD · Principal investigatorMore trials in Minneapolis

NC

OH

  • Cincinnati Children's Hospital Medical Center · Cincinnati, OH 45229Robin Norris, MD · Study contactMore trials in Cincinnati

OR

  • Oregon Health & Science University · Portland, OR 97239Bill Chang, MD · Principal investigatorMore trials in Portland

PA

TX

  • University of Texas, Southwestern · Dallas, TX 75235Tamra Slone, MD · Study contactMore trials in Dallas
  • Baylor Texas Children's Hospital · Houston, TX 77030Karen Rabin, M.D. · Study contactMore trials in Houston

UT