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.
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…
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