Caloric Restriction and Activity for B-cell Leukemia

Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL

Recruiting Phase 2 Interventional Study
B-cell Acute Lymphoblastic Leukemia Obesity
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.

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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 re…
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 …
Contacts

Ellynore Florendo

323-361-3022

eflorendo@chla.usc.edu

CONTACT

Suganya Rajendran

323-361-8835

srajendran@chla.usc.edu

CONTACT