NCT05082519: IDEAL2

Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL

Recruiting now Phase 2 Last updated 26 October 2023

What this trial tests

Phase 2 trial testing IDEAL2 Intervention in B-cell Acute Lymphoblastic Leukemia in 240 participants. Currently enrolling.

Timeline

12 March 2022

Primary endpoint
15 October 2026

15 October 2031

Quick facts

Lead sponsor	Etan Orgel
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	240
Start date	12 March 2022
Primary completion	15 October 2026
Estimated completion	15 October 2031
Sites	20 locations across United States

Drugs / interventions tested

• IDEAL2 Intervention

Conditions studied

• B-cell Acute Lymphoblastic Leukemia — all drugs for B-cell Acute Lymphoblastic Leukemia →
• Obesity — all drugs for Obesity →

Sponsor

Etan Orgel

Who can join

Adults 10 to 25, any sex, with B-cell Acute Lymphoblastic Leukemia or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Obesity and Cancer: A Current Overview of Epidemiology, Pathogenesis, Outcomes, and Management.
   Pati S, Irfan W, Jameel A, Ahmed S, et al · · 2023 · cited 393× · PMID 36672434 · DOI 10.3390/cancers15020485
2. Science-Driven Nutritional Interventions for the Prevention and Treatment of Cancer.
   Montégut L, de Cabo R, Zitvogel L, Kroemer G. · · 2022 · cited 32× · PMID 35997502 · DOI 10.1158/2159-8290.cd-22-0504
3. Dietary Interventions in Cancer Treatment and Response: A Comprehensive Review.
   Mercier BD, Tizpa E, Philip EJ, Feng Q, et al · · 2022 · cited 28× · PMID 36291933 · DOI 10.3390/cancers14205149
4. Novel pharmacological and dietary approaches to target mTOR in B-cell acute lymphoblastic leukemia.
   Buono R, Alhaddad M, Fruman DA. · · 2023 · cited 3× · PMID 37124486 · DOI 10.3389/fonc.2023.1162694
5. The advent of precision nutrigeroscience in cancer: from clinic towards molecular biology.
   Gao Z, Liu Y, Cui Y, Han Y, et al · · 2026 · cited 2× · PMID 40850675 · DOI 10.1016/j.jare.2025.08.034
6. Food for Thought: Addressing a Research Gap for Dietary Trials in Hematologic Malignancies.
   Patel A, Kassam S, Shah UA. · · 2025 · cited 2× · PMID 40778663 · DOI 10.1158/2643-3230.bcd-25-0141
7. Need for consensus on primary end points and efficacy definitions in trials for adult acute lymphoblastic leukemia.
   Wieduwilt MJ. · · 2024 · cited 2× · PMID 38717864 · DOI 10.1182/bloodadvances.2023010449