B-cell Acute Lymphoblastic Leukemia study: IDEAL2 Intervention
Official title Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL
ClinicalTrials.gov ID: NCT05082519
What this study is testing
- What it's testing
- This study is testing whether a personalized diet and exercise plan during chemo can make the cancer more sensitive to treatment and reduce weight gain.
- Who it's for
- You may be able to join if you are a child, teen, or young adult with B‑cell leukemia and have a higher amount of body fat.
- What's involved
- You will follow a custom meal plan and exercise routine while receiving your usual chemo. You will have regular check‑ins and blood tests to see how the cancer and your weight are changing.
- Time commitment
- The study lasts about one month of chemo, with daily diet and exercise guidance and several clinic visits during that time.
- Phase 2: a mid-size study of how well it works
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 25
You may be able to join if
- Patients must be ≥ 7.0 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...
- 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...
You likely can't join if
- Patient will be excluded if they are underweight at time of enrollment (BMI% \<5th percentile for age for patients age 10-19 years, BMI \<18.5 in...
- Patients with Down syndrome or a DNA fragility syndrome (such as Fanconi anemia, Bloom syndrome) will be excluded.
- Patient receiving a SJCRH-style "Total Therapy" regimen will be excluded.
- Patients receiving anti-CD20 monoclonal antibody therapy during induction therapy.
- Patients will be excluded if they received treatment for a previous malignancy.
- Patient will be excluded if they are pregnant.
See the full eligibility criteria
- Patients must be ≥ 7.0 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...
- 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 urine or serum pregnancy test is required within two weeks prior to enrollment.
- Patient will be excluded if they are underweight at time of enrollment (BMI% \<5th percentile for age for patients age 10-19 years, BMI \<18.5 in patients 20-29 years).
- Patients with Down syndrome or a DNA fragility syndrome (such as Fanconi anemia, Bloom syndrome) will be excluded.
- Patient receiving a SJCRH-style "Total Therapy" regimen will be excluded.
- Patients receiving anti-CD20 monoclonal antibody therapy during induction therapy.
- Patients will be excluded if they received treatment for a previous malignancy.
- Patient will be excluded if they are pregnant.
- Patient will be excluded if they have a pre-diagnosis requirement for enteral or parenteral supplementation .
- Patient will be excluded due to inability to perform the intervention (e.g., specific nutritional needs, severe developmental delay, paraplegia)
- Patients will be excluded if they have significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with the protocol treatment or procedures...
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Orange, California, United States
- San Francisco, California, United States
- Denver, Colorado, United States
- Chicago, Illinois, United States
- Kansas City, Kansas, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- Charlotte, North Carolina, United States
- Cincinnati, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Orange, California, United States; San Francisco, California, United States; Denver, Colorado, United States; Chicago, Illinois, United States; Kansas City, Kansas, United States and 9 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.