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NCT05082519 · ClinicalTrials.gov record · last posted 2026-08-19

Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL

Study acronym: IDEAL2
StatusRecruiting
PhasePhase 2
SponsorEtan Orgel
Started2022-03-12
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 3 changes detected by DataLookout

2026-08-20
minor
Trial sites reduced: 20 → 16 locations
2026-08-20
critical
Primary completion pushed: 2026-10-15 → 2027-08-15
2026-08-20
minor
Completion pushed: 2031-10-15 → 2032-08-15
Trial Details
NCT Number NCT05082519
Lead Sponsor Etan Orgel
Collaborators: Therapeutic Advances in Childhood Leukemia Consortium
Conditions B-cell Acute Lymphoblastic Leukemia, Obesity
Enrollment 240 participants
Start Date 2022-03-12
Primary Completion 2027-08-15 (estimated)
Study Completion 2032-08-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-19