B-cell Acute Lymphoblastic LeukemiaPhase 2IDEAL2NCT05082519

Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL

A Phase 2 study testing IDEAL2 Intervention in people with B-cell Acute Lymphoblastic Leukemia and Obesity, run by Etan Orgel at 16 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 7 to 25 years
Conditions the study is for: B-cell Acute Lymphoblastic Leukemia, Obesity
What is being tested?: IDEAL2 Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 16 sitesUnited States
Study dates: 12 Mar 2022to 15 Aug 2032
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 7 to 25 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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 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 urine or serum pregnancy test is required within two weeks prior to enrollment.

Who cannot join

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.

Show all 9Show fewer

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, interfere with consent, study participation, follow up, or interpretation of study results

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ellynore Florendo contact

323-361-3022

eflorendo@chla.usc.edu

Suganya Rajendran contact

323-361-8835

srajendran@chla.usc.edu

City, postcode or hospital

Sites recruiting now only

16 sites in 1 country

United States16 sites, 16 recruiting

C.S. Mott University of Michigan
Ann Arbor, Michigan, 48109
Jennifer Agrusa, M.D.
Recruiting
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322
Melinda Pauly, MD
Not yet recruiting
Levine Children's Hospital
Charlotte, North Carolina, 28203
Joel Kaplan, DO
Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Jenna Rossoff, MD
Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Robin Norris, MD
Recruiting
University of Texas, Southwestern
Dallas, Texas, 75235
Tamra Slone, MD
Recruiting
Colorado Children's Hospital
Denver, Colorado, 80045
Lisa Hartman, M.D.
Recruiting
Baylor Texas Children's Hospital
Houston, Texas, 77030
Karen Rabin, M.D.
Recruiting
Children's Mercy Hospital
Kansas City, Kansas, 64108
Keith August, MD
Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Etan Orgel, MD
Recruiting
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404
Nathan Gossai, MD
Recruiting
Children's Hospital Orange County
Orange, California, 92868
Van Huynh, MD
Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Susan Rheingold, MD
Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Bill Chang, MD
Recruiting
Primary Children's Hospital
Salt Lake City, Utah, 84113
Mallorie Heneghan, M.D.
Recruiting
UCSF School of Medicine
San Francisco, California, 94158
Michelle Hermiston, MD
Recruiting

Other trials in United States

About this study

Official title: A Phase 2 Randomized Trial of Caloric Restriction and Activity to Reduce Chemoresistance in B-cell Acute Lymphoblastic Leukemia

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.

Read the detailed description

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

To examine efficacy of the IDEAL2 (Improving Diet and Exercise in ALL) caloric restriction and activity intervention integrated into HR B-ALL induction to reduce incidence of end of induction (EOI) MRD ≥0.01%.
To examine the efficacy of the IDEAL2 intervention to reduce gain in fat mass during induction

1.2 Secondary Objective

To assess self-reported adherence (defined ≥75%) to the diet and activity components of the IDEAL intervention.

1.3 Exploratory Clinical Objectives

To compare rates of continued MRD positivity by end of consolidation (EOC MRD ≥0.01%).
To compare loss of lean mass (LM), physical inactivity, fitness (via two-minute walk test), and motor function (via BOT-2) at EOI and/or at EOC between intervention and control arms
To compare differences in macronutrient and micronutrient intake during induction and at EOC between intervention and control arms
To compare utilization of immunotherapy (CAR, other) and hematopoietic stem cell transplantation (HSCT) between intervention and control arms
To compare event-free survival (EFS), disease-free survival (DFS), and overall survival (OS) between intervention and control arms.
To compare chemotherapy dose-delivery, obesity-associated treatment toxicities (hepatotoxicity, pancreatitis, thrombosis, steroid-induced hyperglycemia, ICU admission, infection) between intervention and control arms
To evaluate the reliability of relative fat mass (RFM) to estimate body fat percentage, FM, and LM as measured by dual-energy X-ray absorptiometry (DXA)
To explore influence of sleep patterns on changes in FM from baseline to EOI and to EOC
To compare patient-reported quality of life (PedsQL scale) between intervention and control arms
To explore the impact of household material hardship (HMH) on dietary intake, activity, and trial primary endpoints of MRD and change in FM

1.4 Exploratory Integrated Biology Objectives

To quantify the effect of the IDEAL2 intervention, obesity, insulin, and adiponectin on PIK3K/AKT, mTOR, MAPK/ERK signaling and NfKB transcription via mass cytometry of ALL cells
To quantify the effect of the IDEAL2 intervention and obesity on differences in adipokines and cytokines circulating in the plasma
To investigate differences in the metabolome in the plasma and bone marrow extra-cellular fluid at diagnosis and at EOI between intervention and control arms
To explore the underlying biology of chemoresistance, obesity, adipocytes, and ALL cells

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.

Conditions: B-cell Acute Lymphoblastic Leukemia, Obesity
Being tested: IDEAL2 Intervention
Keywords: obesity, leukemia, B-cell leukemia, Pediatric obesity, Pediatric ALL
Medical subject headings: Burkitt Lymphoma, Obesity, Leukemia, Leukemia, B-Cell, Pediatric Obesity, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IDEAL2 InterventionBehavioural
Intervention of diet and exercise to improve outcomes for ALL patients

Study groups in NCT05082519
Study group	Role	What they receive
IDEAL2 intervention	Experimental	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. Receives: Behavioral: IDEAL2 Intervention
Control - Standard of Care	No intervention	One-time education of diet and exercise, which is the standard of care for ALL patients during induction.

What is being measured

The primary outcome is the main question the study is designed to answer.

EOI MRD positivity >= 0.01%
To compare the rate of MRD >=0.01% at end of induction between experimental arm and control arm
Measured: 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
Measured: Prior to day 5 until end of induction (~day 35 from start of chemotherapy)

Secondary outcomes (2)

Proportion of patients with >=75% adherence to diet intervention
To assess the self-reported adherence to the diet component of the IDEAL2 intervention
Measured: 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
Measured: Prior to day 5 until end of induction (~day 35 from start of chemotherapy)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Mar 202215 Aug 2032

First posted19 Oct 2021
Study start12 Mar 2022
Primary completion15 Aug 2027 (estimated)
Study completion15 Aug 2032 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for B-cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a randomized Phase 2 study in patients with HR B-ALL comparing the efficacy of one-time education + the IDEAL2 intervention (experimental) versus one-time education alone (control) in reducing the rate (probability) of having detectable minimum residual disease at the end of induction therapy (EOI MRD) and in reducing the amount of fat gained during induction. Eligible patients will be randomized 1:1 to either the experimental or control arms using stratified, blocked randomization within four strata defined by presenting WBC (\< 50K/uL, ≥ 50K/uL) and body mass index (normal weight vs overweight/obese).
Masking: None (open label)
Enrolment: 240 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05082519
Sponsor's protocol ID: T2020-003
Acronym: IDEAL2
Status last verified: Aug 2026
First submitted: 22 Sep 2021
Last updated: 19 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Randomized Trial of Caloric Restriction and Activity to Reduce Chemoresistance in B-cell Acute Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT05082519
Acronym / sponsor ID: IDEAL2 / T2020-003
Conditions: B-cell Acute Lymphoblastic Leukemia, Obesity
Keywords: obesity, leukemia, B-cell leukemia, Pediatric obesity, Pediatric ALL
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 240 participants (estimated)
Lead sponsor: Etan OrgelUniversity, hospital or other
Collaborators: Therapeutic Advances in Childhood Leukemia Consortium
Study start: 12 Mar 2022 (actual)
Primary completion: 15 Aug 2027 (estimated)
Study completion: 15 Aug 2032 (estimated)
First posted: 19 Oct 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

GOALS AND OBJECTIVES

1.1 Primary Objectives

To examine efficacy of the IDEAL2 (Improving Diet and Exercise in ALL) caloric restriction and activity intervention integrated into HR B-ALL induction to reduce incidence of end of induction (EOI) MRD ≥0.01%.
To examine the efficacy of the IDEAL2 intervention to reduce gain in fat mass during induction

1.2 Secondary Objective

To assess self-reported adherence (defined ≥75%) to the diet and activity components of the IDEAL intervention.

1.3 Exploratory Clinical Objectives

To compare rates of continued MRD positivity by end of consolidation (EOC MRD ≥0.01%).
To compare loss of lean mass (LM), physical inactivity, fitness (via two-minute walk test), and motor function (via BOT-2) at EOI and/or at EOC between intervention and control arms
To compare differences in macronutrient and micronutrient intake during induction and at EOC between intervention and control arms
To compare utilization of immunotherapy (CAR, other) and hematopoietic stem cell transplantation (HSCT) between intervention and control arms
To compare event-free survival (EFS), disease-free survival (DFS), and overall survival (OS) between intervention and control arms.
To compare chemotherapy dose-delivery, obesity-associated treatment toxicities (hepatotoxicity, pancreatitis, thrombosis, steroid-induced hyperglycemia, ICU admission, infection) between intervention and control arms
To evaluate the reliability of relative fat mass (RFM) to estimate body fat percentage, FM, and LM as measured by dual-energy X-ray absorptiometry (DXA)
To explore influence of sleep patterns on changes in FM from baseline to EOI and to EOC
To compare patient-reported quality of life (PedsQL scale) between intervention and control arms
To explore the impact of household material hardship (HMH) on dietary intake, activity, and trial primary endpoints of MRD and change in FM

1.4 Exploratory Integrated Biology Objectives

To quantify the effect of the IDEAL2 intervention, obesity, insulin, and adiponectin on PIK3K/AKT, mTOR, MAPK/ERK signaling and NfKB transcription via mass cytometry of ALL cells
To quantify the effect of the IDEAL2 intervention and obesity on differences in adipokines and cytokines circulating in the plasma
To investigate differences in the metabolome in the plasma and bone marrow extra-cellular fluid at diagnosis and at EOI between intervention and control arms
To explore the underlying biology of chemoresistance, obesity, adipocytes, and ALL cells

OUTLINE: Patients are randomized to 1 of 2 arms

CONTROL ARM: One-time standard of care nutritional education session

All patients receive standard of care B-ALL chemotherapy.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This is a randomized Phase 2 study in patients with HR B-ALL comparing the efficacy of one-time education + the IDEAL2 intervention (experimental) versus one-time education alone (control) in reducing the rate (probability) of having detectable minimum residual disease at the end of induction therapy (EOI MRD) and in reducing the amount of fat gained during induction. Eligible patients will be randomized 1:1 to either the experimental or control arms using stratified, blocked randomization within four strata defined by presenting WBC (< 50K/uL, ≥ 50K/uL) and body mass index (normal weight vs overweight/obese).

Arm	Type	Receives
IDEAL2 intervention	Experimental	Behavioral: IDEAL2 InterventionFocused 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.
Control - Standard of Care	No intervention	–One-time education of diet and exercise, which is the standard of care for ALL patients during induction.

Who may qualify

Ages: 7 to 25 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (8 listed)

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 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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IDEAL2 InterventionIntervention of diet and exercise to improve outcomes for ALL patients	Behavioural	IDEAL2 intervention

Primary outcome

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

2 secondary outcomes

Proportion of patients with >=75% adherence to diet 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
Time frame: Prior to day 5 until end of induction (~day 35 from start of chemotherapy)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Ellynore Florendo contact

323-361-3022

eflorendo@chla.usc.edu

Suganya Rajendran contact

323-361-8835

srajendran@chla.usc.edu

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IDEAL2 Intervention in people with B-cell Acute Lymphoblastic Leukemia and Obesity, run by Etan Orgel at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ellynore Florendo (323-361-3022, eflorendo@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EOI MRD positivity >= 0.01% (time frame: Prior to day 5 until end of induction (~day 35 from start of chemotherapy)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05082519.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.