Actively Recruiting
Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL
Led by Etan Orgel · Updated on 2023-10-26
240
Participants Needed
20
Research Sites
500 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 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
Official Title
Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 10.0 to less than 26.0 years old.
- Patients must have a diagnosis of new (de novo) B-cell Acute Lymphoblastic Leukemia (B-ALL).
- Patients must have M3 marrow (>25% blasts) or at least 1,000 circulating leukemia cells per microliter confirmed by flow cytometry or equivalent evidence.
- This must be the first treatment attempt for B-ALL.
- Treatment must be a multi-agent induction regimen including vincristine, glucocorticoid, pegaspargase/calaspargase, and daunorubicin or doxorubicin, planned for less than 35 days.
- Organ function must meet requirements for starting chemotherapy.
- Patients must have Karnofsky score > 50% if older than 16 years or Lansky score > 50% if 16 years or younger (or expected to recover by Day 8).
- Females of childbearing potential must have a negative pregnancy test within two weeks before enrollment.
You will not qualify if you...
- Patients who are underweight at enrollment (BMI below 5th percentile for age if 10-19 years old or BMI below 18.5 if 20-29 years old).
- Patients with Down syndrome or DNA fragility syndromes such as Fanconi anemia or Bloom syndrome.
- Patients receiving a SJCRH-style "Total Therapy" regimen.
- Patients receiving anti-CD20 monoclonal antibody therapy during induction.
- Patients who have received treatment for a previous cancer.
- Pregnant patients.
- Patients requiring enteral or parenteral nutritional supplementation before diagnosis.
- Patients unable to perform the diet and exercise intervention (e.g., severe developmental delay, paraplegia).
- Patients with significant other illnesses, psychiatric disorders, or social issues that would affect safety, compliance, consent, participation, follow-up, or study results.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
R
Roy Leong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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