A Phase 2 interventional study of IDEAL2 Intervention in B-cell Acute Lymphoblastic Leukemia and Obesity, sponsored by Etan Orgel. Recruiting at 16 sites in United States. Open to participants aged 7 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Etan Orgel · Phase 2, Interventional, and Supportive care
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.
GOALS AND OBJECTIVES
Hypothesis: Caloric restriction with increased physical activity integrated into induction chemotherapy will decrease chemoresistance and reduce minimal residual disease (MRD). In children receiving induction therapy for NCI/Rome high-risk B-cell acute lymphoblastic leukemia (HR B-ALL),
1.1 Primary Objectives
1.2 Secondary Objective
1.3 Exploratory Clinical Objectives
1.4 Exploratory Integrated Biology Objectives
OUTLINE: Patients are randomized to 1 of 2 arms
EXPERIMENTAL ARM: Standard of care nutrition education plus the updated "Improving Diet and Exercise in ALL" (IDEAL2) intervention to achieve calorie restriction through a personalized nutritional program and increased activity/exercise.
CONTROL ARM: One-time standard of care nutritional education session
All patients receive standard of care B-ALL chemotherapy.
976 studies on the registry are indexed under Burkitt Lymphoma; 159 are open to participants now.
This study's planned enrollment of 240 is above the median of 36 across 765 interventional studies indexed under Burkitt Lymphoma.
Browse Burkitt Lymphoma studies →Etan Orgel is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: IDEAL2 Intervention
One-time education of diet and exercise, which is the standard of care for ALL patients during induction.
Intervention of diet and exercise to improve outcomes for ALL patients
EOI MRD positivity >= 0.01%
To compare the rate of MRD \>=0.01% at end of induction between experimental arm and control arm
Time frame: Prior to day 5 until end of induction (~day 35 from start of chemotherapy)
Change in fat mass
To compare the % change in fat mass from baseline to end of induction between the experimental arm and control arm
Time frame: Prior to day 5 until end of induction (~day 35 from start of chemotherapy)
Proportion of patients with >=75% adherence to diet intervention
To assess the self-reported adherence to the diet component of the IDEAL2 intervention
Time frame: Prior to day 5 until end of induction (~day 35 from start of chemotherapy)
Proportion of patients with >=75% adherence to exercise intervention
To assess the self-reported adherence to the exercise component of the IDEAL2 intervention
Time frame: Prior to day 5 until end of induction (~day 35 from start of chemotherapy)
Started Mar 2022 (actual). Primary completion is estimated for Aug 2027, 65 months after the start.
Of 83 non-industry phase 2 interventional studies under Burkitt Lymphoma, half reached primary completion within 83 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 120. This study's planned 65 months is below that.
Counting every sponsor, half of 91 studies reached it within 81 months; a quarter within 41 and three quarters within 119.
How these figures are worked out, and which studies are left out of them.
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Etan Orgel