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.
Participant has acute lymphoblastic leukemia (ALL), Hodgkin lymphoma, or non-Hodgkin lymphoma.
Participant has achieved remission and is completing outpatient, maintenance therapy with no further planned inpatient therapy and no use of experimental or investigational treatment OR participant is up to 27 months off therapy (to allow patients who return for 2 year off therapy visits slightly beyond the time point to remain eligible).
Participant will have completed all cycles of therapy that include corticosteroids at the time of study
Participant is age ≥12 and <25-yrs at study entry
Participant has had recent, ongoing weight loss (≥5 kg in past 3-months).
Participant has diabetes mellitus (type 1 or 2 currently on medication or with Hemoglobin A1c ≥6.5%). Participants with a history of steroid induced diabetes requiring insulin who are no longer meet criteria for diabetes, are off any insulin for the past 3 months and have no further planned steroid exposure are eligible.
Participant has poorly controlled hypertensions: current blood pressure
140/90 on 3 separate occasions (and for age 12 > 95th percentile on 3 separate occasions) or recent change in anti-hypertensive medication that has not been stable for 3 months
Parallel
Phentermine/Topiramate ER
DrugGiven orally once daily for 24 weeks using dose escalation consistent with FDA-approved obesity treatment guidelines.
Health Behavior and Lifestyle Counseling
BehavioralDietary, 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.
Determine feasibility of obesity treatment with phentermine/topiramate ER plus health behavior and lifestyle counseling (PHEN/TOP) versus lifestyle counseling alone (SOC) in adolescents and young adults with ALL or lymphoma.
Participation measured by acceptance of the intervention evidenced by the participation rate (proportion of potentially eligible persons who were approached who enroll on study).
Determine the feasibility of completing obesity treatment with phentermine/topiramate ER plus health behavior and lifestyle counseling (PHEN/TOP) versus lifestyle counseling alone as standard care in adolescents and young adults with ALL or lymphoma.
Completion measured by proportion of patients randomized to the PHEN/TOP arm completing the treatment phase of the study, defined by completion of the week 24 study visit irrespective of adherence to pharmacotherapy.
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.
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.
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