Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL (NCT05082519)
A Phase 2 Randomized Trial of Caloric Restriction and Activity to Reduce Chemoresistance in B-cell Acute Lymphoblastic Leukemia
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital Los Angeles — Los Angeles, California
Age range: 7 Years to 25 Years
🧪 Interventions in This Study
- IDEAL2 Intervention (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (16 Sites)
- Children's Hospital Los Angeles — Los Angeles, California
- Children's Hospital Orange County — Orange, California
- UCSF School of Medicine — San Francisco, California
- Colorado Children's Hospital — Denver, Colorado
- Children's Healthcare of Atlanta at Egleston — Atlanta, Georgia
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois
- Children's Mercy Hospital — Kansas City, Kansas
- C.S. Mott University of Michigan — Ann Arbor, Michigan
- Children's Hospitals and Clinics of Minnesota — Minneapolis, Minnesota
- Levine Children's Hospital — Charlotte, North Carolina
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
- Oregon Health & Science University — Portland, Oregon
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- University of Texas, Southwestern — Dallas, Texas
- Baylor Texas Children's Hospital — Houston, Texas
- Primary Children's Hospital — Salt Lake City, Utah
📞 Contact the Study Coordinator
Phone: (323) 361-3022
Email: eflorendo@chla.usc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in B-cell Acute Lymphoblastic Leukemia
- A Second Infusion (Early Reinfusion) of Tisagenlecleucel in Children and Young Adults With B-Cell Acute Lymphoblastic Leukemia(B-ALL) — Los Angeles, California
- A Phase 1b/2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Combination With Low Intensity Chemotherapy in Older Patients With Newly Diagnosed B-Cell Acute Lymphoblastic Leukemia — Houston, Texas
- Venetoclax Plus Inotuzumab for B-ALL — Boston, Massachusetts
- Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients — Birmingham, Alabama
- Study Of KITE-753 in R/R B-Cell ALL — Houston, Texas
- A Study of Inotuzumab and Blinatumomab in People With B-cell Acute Lymphoblastic Leukemia — New York, New York
Explore by condition: All B-cell Acute Lymphoblastic Leukemia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.