Obesity / overweight

Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL

Recruiting · 20 sites across 15 states

✓ PHASE2

Always free

Study care at no cost to you

For your time and travel

Many studies pay you back

Most need no insurance or papers

Legal status usually isn't required; we'll tell you each study's requirements

Interpreters available

Ask for your language

Your choice

Voluntary — you can stop anytime

What is this study?

It is , overseen by an independent and licensed medical staff.

Read the full clinical 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. 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 this study is looking for

In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.

✅ You may be able to join if…

•Age 10 to under 26 years
•Has been diagnosed with de novo B-ALL
•Is starting their first B-ALL treatment with a multi-drug induction plan that includes vincristine, glucocorticoid, pegaspargase or calaspargase, and daunorubicin or doxorubicin, with planned duration under 35 days
•Has bone marrow or blood test results that show B-ALL at the required level (M3 marrow >25% blasts or at least 1,000 leukemia cells/µL in blood confirmed by flow cytometry, or convincing central review evidence)
•If female and able to have a child, has a negative pregnancy test within two weeks before enrollment

🚫 You may not be able to join if…

•Underweight at enrollment (BMI <5th percentile for age if 10–19, or BMI <18.5 if 20–29)
•Has Down syndrome or a DNA fragility syndrome such as Fanconi anemia or Bloom syndrome
•Is receiving a SJCRH-style “Total Therapy” regimen
•Received an anti-CD20 monoclonal antibody during induction
•Is pregnant (also excluded if they must have enteral or parenteral supplementation before diagnosis, cannot do the intervention, or have a serious issue that would affect safety, consent, follow-up, or study procedures)

Are you a good fit?

Simplified highlights. The study team always confirms the full details with you.

✓Adults roughly 10–25

!Some conditions may not be a fit: Obesity / overweight
!Not for people who are pregnant or breastfeeding

What to expect, step by step

1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.

Has this treatment been tested before?

Yes. This treatment has already been through earlier human studies for safety before reaching this stage.

What you need to know before you apply

What is this study testing?+

Is it safe? Who makes sure of that?+

This is a mid-stage study (Phase 2), looking at safety and whether the treatment works. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.

Will I get a placebo instead of the real treatment?+

Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.

Do I have to stop taking my current medications?+

It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.

Does it cost anything? Will I be paid?+

Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.

Do I need insurance? Will anyone ask about my immigration status?+

No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.

What if English isn't my first language?+

You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.

Is my information private?+

Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.

Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.

Source: ClinicalTrials.gov · NCT05082519 · Locations: California · Colorado · Georgia · Illinois · Maryland · Michigan · Minnesota · New York · North Carolina · Ohio · Oregon · Pennsylvania · Texas · Utah · Wisconsin