What side effects are associated with this type of intervention?

Common treatments for Acute Lymphoblastic Leukemia (ALL), particularly chemotherapy, can cause side effects such as neutropenia, thrombocytopenia, anemia, nausea, vomiting, hair loss, and increased susceptibility to infections. Chemotherapy can also lead to significant weight gain due to increased body fat. Caloric restriction during chemotherapy is being studied to reduce this weight gain and enhance the effectiveness of the treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for Acute Lymphoblastic Leukemia (ALL), including chemotherapeutic agents, targeted therapies, and immunotherapies. Key drugs include asparaginase, methotrexate, and vincristine, which are often used in combination regimens. More recent approvals include blinatumomab, a bispecific T-cell engager, and inotuzumab ozogamicin, an antibody-drug conjugate. Additionally, CAR-T cell therapies like tisagenlecleucel have been approved for relapsed or refractory ALL. These treatments aim to improve chemotherapy sensitivity and outcomes, though specific strategies to reduce body fat gain during treatment, as studied in the caloric restriction trial, are not typically the primary focus of these approvals.

What other types of research exist?

Promising novel alternatives to caloric restriction for ALL patients include: 1) Personalized exercise programs, which can help manage body fat and improve chemotherapy outcomes. 2) Pharmacological agents like leptin receptor modulators, which may address leptin insensitivity and related metabolic issues. 3) Nutritional supplements such as eicosapentaenoic acid (EPA), which have shown benefits in managing body composition and enhancing treatment efficacy. These alternatives should be discussed with a healthcare provider to tailor the best approach for individual patients.

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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

Must not have

Patients receiving anti-CD20 monoclonal antibody therapy during induction therapy

Patient receiving a SJCRH-style 'Total Therapy' regimen will be excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior to day 5 until end of induction (~day 35 from start of chemotherapy)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a personalized diet and exercise plan can help older children, adolescents, and young adults with high-risk B-cell Acute Lymphoblastic Leukemia respond better to chemotherapy. The plan aims to reduce body fat, which is linked to treatment resistance, and limit fat gain during chemotherapy.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently receiving anti-CD20 monoclonal antibody therapy.

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I am not on a SJCRH-style 'Total Therapy' regimen.

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I do not have Down syndrome or a DNA fragility syndrome like Fanconi anemia.

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I am not underweight according to BMI standards for my age group.

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I have not been treated for another cancer type.

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I do not need tube feeding or IV nutrition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to day 5 until end of induction (~day 35 from start of chemotherapy)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in fat mass

EOI MRD positivity >= 0.01%

Secondary study objectives

Proportion of patients with >=75% adherence to diet intervention

Proportion of patients with >=75% adherence to exercise intervention

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Acute Lymphoblastic Leukemia (ALL) involve chemotherapy, which targets rapidly dividing cells to inhibit DNA replication and cell division, leading to cancer cell death. Drugs like methotrexate, vincristine, and corticosteroids are commonly used. The importance of these treatments lies in their ability to effectively reduce the leukemic cell population. The trial on caloric restriction aims to enhance chemotherapy sensitivity and reduce body fat gain, which is crucial because higher body fat is linked to chemotherapy resistance. By improving the effectiveness of chemotherapy and managing body composition, treatment outcomes for ALL patients can be significantly enhanced.

A prospective study on changes in body composition and fat percentage during the first year of cancer treatment in children.