Obesity Treatment Using Phentermine-Topiramate ER to Improve Metabolic Health in Adolescents and Young Adults Surviving Leukemia and Lymphoma
St. Jude Children's Research Hospital
Summary
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.
Description
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…
Eligibility
- Age range
- 12–24 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DrugPhentermine/Topiramate ER
Given orally once daily for 24 weeks using dose escalation consistent with FDA-approved obesity treatment guidelines.
- BehavioralHealth Behavior and Lifestyle Counseling
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.
Location
- St. Jude Children's Research HospitalMemphis, Tennessee