No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
7 – 25
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Supportive Care
Participants needed
240 (estimated)
Sponsor
Etan Orgel · Other
Who this trial is looking for
This trial is looking for older children and young adults with B-cell Acute Lymphoblastic Leukemia (B-ALL). Participants will follow a personalized nutrition and exercise plan during their chemotherapy to see if it helps reduce side effects and makes the treatment more effective.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 7 and 25 years old.
I have been diagnosed with B-cell Acute Lymphoblastic Leukemia.
I have a certain level of leukemia cells in my blood.
This is my first treatment attempt for B-ALL.
I am starting a specific combination of chemotherapy drugs.
I have acceptable organ function to start chemotherapy.
I have a good performance status at the time of diagnosis.
If I am female, I have a negative pregnancy test.
You may not be able to join if
I am underweight.
I have Down syndrome or a DNA fragility syndrome.
I am receiving a specific 'Total Therapy' regimen.
I am receiving anti-CD20 monoclonal antibody therapy.
I have had treatment for a previous cancer.
I am pregnant.
I require special nutrition support before diagnosis.
I have a serious health issue that affects my safety.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 re…
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.
Trial Locations
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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 …
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
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