NCT05082519 · Etan Orgel
Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL
(IDEAL2)
What this study 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.
View original scientific 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.
Interventions
BEHAVIORAL
IDEAL2 Intervention
Intervention of diet and exercise to improve outcomes for ALL patients
Primary outcome measures
EOI MRD positivity >= 0.01%
Time frame: Prior to day 5 until end of induction (~day 35 from start of chemotherapy)
To compare the rate of MRD \>=0.01% at end of induction between experimental arm and control arm
Change in fat mass
Time frame: Prior to day 5 until end of induction (~day 35 from start of chemotherapy)
To compare the % change in fat mass from baseline to end of induction between the experimental arm and control arm
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients must be ≥ 10.0 and \<26.0 years of age.
- Patients must have a diagnosis of de novo B-ALL
- Patients must have a M3 marrow (\>25% blasts by morphology) or at least 1,000/µL circulating leukemia cells in PB confirmed by Flow Cytometry (or other convincing evidence of a B-ALL diagnosis not meeting above criteria following central review by the Study Hematopathologist and Study Chair or Vice-Chair).
- The treatment regimen must be the first treatment attempt for B-ALL-
- Must be a multi-agent induction regimen inclusive of vincristine, glucocorticoid, pegaspargase/calaspargase, and daunorubicin or doxorubicin and with a planned duration \<35 days.
- Organ function must meet that required for initiation of chemotherapy
- Patients at diagnosis must meet Karnofsky \> 50% for patients \> 16 years of age and Lansky \> 50% for patients ≤ 16 years of age (or be expected to recover prior to Day 8) .
- If the patient is a female of childbearing potential, a negative
Where
- Los Angeles, California
- Orange, California
- San Francisco, California
- Denver, Colorado
- Atlanta, Georgia
- Chicago, Illinois
- Baltimore, Maryland
- Ann Arbor, Michigan
- Minneapolis, Minnesota
- New York, New York
- Charlotte, North Carolina
- Cincinnati, Ohio
And 8 more locations — see the full list below.
Collaborators
Therapeutic Advances in Childhood Leukemia Consortium
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 26, 2023 · Source of record for eligibility and locations