This study is evaluating whether a weight-loss medication (PHEN/TOP) combined with healthy lifestyle counseling is safe, well tolerated, and can help reduce obesity in adolescents and young adults who are in remission from ALL, Hodgkin lymphoma, or non-Hodgkin lymphoma. Participants are randomly assigned to receive either PHEN/TOP plus counseling or counseling alone for 24 weeks and are followed for up to 52 weeks.
Survivors of childhood leukemia and lymphoma are at increased risk for obesity and cardiometabolic complications during treatment and early survivorship. The OPTIMAL study is evaluating whether adding the FDA-approved weight-loss medication phentermine-topiramate extended release (ER) to healthy lifestyle counseling is practical, safe, and may improve weight-related outcomes in survivors of leukemia and lymphoma with obesity. The study will enroll participants ages 12 to under 25 years who are in remission from acute lymphoblastic leukemia (ALL), Hodgkin lymphoma, or non-Hodgkin lymphoma and are completing outpatient therapy or are within approximately 2 years of therapy completion. Participants assigned to the intervention arm will receive daily phentermine-topiramate ER with dose escalation according to FDA-approved obesity treatment guidelines in addition to counseling every 4 weeks. Participants assigned to the control arm will receive counseling alone. The intervention period lasts 24 weeks, followed by an observational follow-up visit at week 52 to assess durability of response. Researchers will assess study participation and completion rates, medication safety and tolerability, and changes in body weight and BMI. The study will also explore effects on body composition, heart and metabolic health, physical activity, eating habits, cognitive function, and quality of life. Primary Objective: * Determine the feasibility of obesity treatment using combination phentermine and extended-release topiramate plus health behavior and lifestyle counselling (PHEN/TOP) compared to health behavior and lifestyle counselling alone as standard of care (SOC) in adolescent and young adult patients with ALL or lymphoma and obesity who have achieved remission and are completing outpatient, maintenance therapy or in the first 2 years of survivorship. Secondary Objective: * Determine the tolerability of PHEN/TOP compared to SOC alone in adolescent and young adult patients with ALL or lymphoma and obesity. * Estimate preliminary efficacy of PHEN/TOP compared to SOC for change in body mass index (BMI) in adolescent and young adult patients with ALL or lymphoma and obesity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Given orally once daily for 24 weeks using dose escalation consistent with FDA-approved obesity treatment guidelines.
Dietary, physical activity, and behavior modification counseling delivered every 4 weeks by trained study personnel. Counseling targets approximately a 500-calorie/day deficit and reinforces healthy lifestyle behaviors.
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Determine feasibility of obesity treatment with phentermine/extended-release topiramate (PHEN/TOP) compared to lifestyle alone (SOC) in patients 12-<25 years with ALL or lymphoma and obesity in maintenance therapy or up to 2 years off therapy.
Feasibility will be defined as 1) participation rate (proportion of potentially eligible persons approached who enroll and are randomized) and 2) completion rate (proportion of participants randomized to the intervention arm completing study)
Time frame: Baseline and Week 24
Determine the tolerability of PHEN/TOP compared to SOC alone in adolescent and young adult patients with ALL or lymphoma and obesity.
Tolerability measured by frequency of adverse events (AEs, using Common Terminology Criteria for Adverse Events \[CTCAE\]) and proportion of participants who discontinue PHEN/TOP due to AEs. We will also report the proportion of patients who complete study on a therapeutic dose as top-dose and mid-dose PHEN/TOP.
Time frame: Week 24
Estimate preliminary efficacy of PHEN/TOP compared to SOC for change in body mass index (BMI) in adolescent and young adult patients with ALL or lymphoma and obesity.
Primary measure of efficacy will be the proportion of participants in each arm who achieve at least 5% BMI reduction from baseline to week 24.
Time frame: Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.