Actively Recruiting
A Phase 2 Randomized Trial of Caloric Restriction and Activity to Reduce Chemoresistance in B-cell Acute Lymphoblastic Leukemia
Led by Etan Orgel · Updated on 2023-10-26
240
Participants Needed
20
Research Sites
260 weeks
Total Duration
On this page
Sponsors
E
Etan Orgel
Lead Sponsor
T
Therapeutic Advances in Childhood Leukemia Consortium
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research focuses on older children, adolescents, and young adults diagnosed with B-cell Acute Lymphoblastic Leukemia (B-ALL). It explores whether reducing calorie intake and increasing physical activity during standard chemotherapy can make the leukemia more responsive to treatment and limit the increase in body fat that usually occurs during the first month of chemotherapy. The study aims to reduce chemoresistance and minimal residual disease (MRD) while addressing treatment-related fat gain. Participants are randomly assigned to one of two groups. One group receives a personalized diet with at least a 15% daily calorie deficit, emphasizing low-fat and low-glycemic carbohydrate intake, combined with moderate exercise five days a week. The control group receives a single standard nutrition education session without the personalized intervention. All participants continue their regular chemotherapy treatment for B-ALL. During the study, participants are monitored from before day 5 until about day 35 of induction chemotherapy. Researchers assess MRD levels, changes in fat mass, adherence to diet and exercise plans, and various physical and metabolic outcomes. Additional evaluations include fitness tests, quality of life questionnaires, immune therapy use, and treatment side effects. The study also explores biological markers related to obesity and chemoresistance to better understand treatment responses.
CONDITIONS
Brief Title
Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 10 years or older and younger than 26 years.
- Patients must have a diagnosis of newly diagnosed B-cell Acute Lymphoblastic Leukemia (B-ALL).
- Patients must have high levels of leukemia cells in bone marrow or blood confirmed by tests.
- This must be the first treatment attempt for B-ALL.
- The chemotherapy plan must include specific drugs and last less than 35 days.
- Organ function must be adequate to start chemotherapy.
- Patients must have a performance status score above 50%, or expected to recover before day 8.
- Female patients who can become pregnant must have a negative pregnancy test within two weeks before enrollment.
You will not qualify if you...
- Patients who are underweight at enrollment (below 5th percentile BMI for ages 10-19, or BMI below 18.5 for ages 20-29).
- Patients with Down syndrome or DNA fragility syndromes such as Fanconi anemia or Bloom syndrome.
- Patients receiving a specific "Total Therapy" regimen.
- Patients receiving anti-CD20 monoclonal antibody therapy during induction.
- Patients who had treatment for a previous cancer.
- Pregnant patients.
- Patients needing feeding support through tubes or intravenous nutrition before diagnosis.
- Patients unable to perform the diet and exercise intervention due to medical or developmental reasons.
- Patients with serious other illnesses, psychiatric conditions, or social issues that affect safety or study participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 35 days
Participants undergo induction chemotherapy for B-cell Acute Lymphoblastic Leukemia while receiving either a diet and exercise intervention or standard nutrition education.
Multiple visits during induction chemotherapy
Trial Site Locations
Total: 20 locations
1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
2
Children's Hospital Orange County
Orange, California, United States, 92868
Actively Recruiting
3
UCSF School of Medicine
San Francisco, California, United States, 94158
Actively Recruiting
4
Colorado Children's Hospital
Denver, Colorado, United States, 80045
Actively Recruiting
5
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
6
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
7
Johns Hopkins / Sydney Kimmel Cancer Center
Baltimore, Maryland, United States, 21231
Not Yet Recruiting
8
C.S. Mott University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
9
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
10
Columbia University Medical Center
New York, New York, United States, 10032
Not Yet Recruiting
11
Levine Children's Hospital
Charlotte, North Carolina, United States, 28203
Actively Recruiting
12
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Not Yet Recruiting
13
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Not Yet Recruiting
14
Oregon Health & Science University
Portland, Oregon, United States, 97239
Not Yet Recruiting
15
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
16
University of Texas, Southwestern
Dallas, Texas, United States, 75235
Actively Recruiting
17
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Not Yet Recruiting
18
Baylor Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
19
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Actively Recruiting
20
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
Research Team
E
Ellynore Florendo
R
Roy Leong
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here