Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age7-25
SponsorEtan Orgel
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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-
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
IDEAL2 Intervention
BehavioralIntervention of diet and exercise to improve outcomes for ALL patients
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: IDEAL2 interventionExperimental treatment 1 intervention
Group B: Control - Standard of CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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)2
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)Secondary outcomes
1
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)2
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Etan Orgel
Lead sponsor
Therapeutic Advances in Childhood Leukemia Consortium
Sponsor institution
Therapeutic Advances in Childhood Leukemia Consortium
Collaborator
Source ClinicalTrials.gov