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.
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At a Glance
Age
10 – 25
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Supportive Care
Participants needed
240 (estimated)
Sponsor
Etan Orgel · Other
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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 ≥ 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…
Contacts

Ellynore Florendo

323-361-3022

eflorendo@chla.usc.edu

CONTACT

Roy Leong

323-361-5132

rleong@chla.usc.edu

CONTACT