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Behavioral Intervention

Caloric Restriction + Activity for Acute Lymphoblastic Leukemia (IDEAL2 Trial)

Phase 2
Recruiting
Research Sponsored by Etan Orgel
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Patients must be ≥ 10.0 and <26.0 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prior to day 5 until end of induction (~day 35 from start of chemotherapy)
Awards & highlights

IDEAL2 Trial Summary

This trial is for 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.

Who is the study for?
This trial is for young people aged 10 to less than 26 with B-cell Acute Lymphoblastic Leukemia (B-ALL) who are starting their first treatment. They must be able to perform moderate exercise and follow a diet plan, have a body mass index above the 5th percentile but not underweight, and cannot be pregnant or have had previous cancer treatments.Check my eligibility
What is being tested?
The IDEAL2 Intervention is being tested to see if caloric restriction through personalized nutrition and exercise can make leukemia cells more sensitive to chemotherapy. The study aims to reduce body fat gained during treatment and improve the effectiveness of chemotherapy.See study design
What are the potential side effects?
Potential side effects may include fatigue due to caloric restriction and physical strain from increased activity levels. However, specific side effects will depend on individual responses to diet changes and exercise routines.

IDEAL2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My leukemia has a high number of blasts in my marrow or blood.
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I am between 10 and 25 years old.
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I have been diagnosed with B-cell Acute Lymphoblastic Leukemia for the first time.
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My first treatment for B-ALL includes specific drugs and lasts less than 35 days.
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My organs are healthy enough for chemotherapy.

IDEAL2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to day 5 until end of induction (~day 35 from start of chemotherapy)
This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to day 5 until end of induction (~day 35 from start of chemotherapy) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in fat mass
EOI MRD positivity >= 0.01%
Secondary outcome measures
Proportion of patients with >=75% adherence to diet intervention
Proportion of patients with >=75% adherence to exercise intervention

IDEAL2 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: IDEAL2 interventionExperimental Treatment1 Intervention
Focused and short-term intervention of diet and exercise during induction. Calorie goal is >=15% daily deficit as determined by each subject's estimated energy requirement. Fat intake will make up <25% of daily calories. Carbohydrate will make up <55% of daily calories consisting of "low" glycemic load foods (<100/2,000 kcal adjusted for daily calories). Protein will make up >=20% of daily calories. Subjects will also perform moderate exercise 5 days per week for 30 minutes/session (total = 150 minutes per week). Subjects will have a step goal to decrease sedentary behavior, with a starting goal of >=1000 steps/day and increasing by at least 1000 steps/day each week.
Group II: Control - Standard of CareActive Control1 Intervention
One-time education of diet and exercise, which is the standard of care for ALL patients during induction.

Find a Location

Who is running the clinical trial?

Etan OrgelLead Sponsor
1 Previous Clinical Trials
Therapeutic Advances in Childhood Leukemia ConsortiumOTHER
20 Previous Clinical Trials
437 Total Patients Enrolled

Media Library

IDEAL2 Intervention (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05082519 — Phase 2
Acute Lymphoblastic Leukemia Research Study Groups: Control - Standard of Care, IDEAL2 intervention
Acute Lymphoblastic Leukemia Clinical Trial 2023: IDEAL2 Intervention Highlights & Side Effects. Trial Name: NCT05082519 — Phase 2
IDEAL2 Intervention (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05082519 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to partake in this experiment?

"This clinical trial has a participant criteria that requires enrollees to have obesity and be within the age range of 10-25. A total of approximately 240 individuals are being recruited for this medical research."

Answered by AI

What is the uppermost limit of participants in this experiment?

"Affirmative. According to clinicaltrials.gov, this research endeavour is still recruiting patients since its initial post on March 12th 2022 and last updated June 23rd 2022. 240 participants are needed from 16 different healthcare facilities."

Answered by AI

Are elderly individuals being included in the study's recruitment process?

"This trial is intended for those aged between 10 and 25. There are 666 trials currently recruiting individuals that fall below the age of consent, while 1778 clinical studies have opened enrollment to participants above 65 years old."

Answered by AI

Is enrollment into this medical trial still available?

"Clinicaltrials.gov reveals that this clinical trial, initially posted on March 12th 2022, is still actively recruiting patients as of June 23rd 2022."

Answered by AI

Is the IDEAL2 Intervention a risk to patient health?

"Our internal assessment at Power has rated IDEAL2 Intervention's safety a 2 due to the fact that there is only limited clinical data available in regards to its efficacy and some amount of evidence provided for its safety."

Answered by AI

What is the scope of this research endeavor in terms of hospital participation?

"This research is open to participants at Children's Hospital Los Angeles in California, Levine Children's Hospital in North carolina, Children's Healthcare of Atlanta at Egleston in Georgia and 16 other clinical sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL
Etan Orgel 2022. "Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05082519.
~127 spots leftby Oct 2026
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