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NCT05082519 · ClinicalTrials.gov registry record · Phase 2
Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL
A Phase 2 study of Obesity and B-cell Acute Lymphoblastic Leukemia, sponsored by Etan Orgel.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 240
- Enrollment target
- 20
- Study locations
NCT05082519 is a Phase 2 study of Obesity and B-cell Acute Lymphoblastic Leukemia that is actively recruiting participants, run by Etan Orgel. The registered enrollment target is 240 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT05082519, a Phase 2 study of Obesity and B-cell Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by Etan Orgel.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 240 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- BEHAVIORAL IDEAL2 Intervention
Study Locations (20)
California
- Children's Hospital Los Angeles - Los Angeles
- Children's Hospital Orange County - Orange
- UCSF School of Medicine - San Francisco
Texas
- University of Texas, Southwestern - Dallas
- Cook Children's Medical Center - Fort Worth
- Baylor Texas Children's Hospital - Houston
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Nationwide Children's Hospital - Columbus
Colorado
- Colorado Children's Hospital - Denver
Georgia
- Children's Healthcare of Atlanta at Egleston - Atlanta
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Maryland
- Johns Hopkins / Sydney Kimmel Cancer Center - Baltimore
Michigan
- C.S. Mott University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2022-03-12 |
| Est. Completion | 2031-10-15 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05082519
The ClinicalTrials.gov registry entry for NCT05082519 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (71% lower). The listed sponsor is Etan Orgel, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which IDEAL2 Intervention is the first listed.
NCT05082519 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Texas, Ohio.
Frequently Asked Questions
What is clinical trial NCT05082519 about?
NCT05082519 is a clinical study titled "Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL". 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 t...
What is the current status of trial NCT05082519?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 2022-03-12. Estimated completion is 2031-10-15.
What conditions does trial NCT05082519 study?
This clinical trial studies the following conditions: Obesity, B-cell Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT05082519?
The interventions under investigation include: IDEAL2 Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT05082519?
This trial is sponsored by Etan Orgel, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05082519 being conducted?
This trial has 20 study locations across California, Colorado, Georgia, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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