Obesity Treatment Using Phentermine-Topiramate ER to Improve Metabolic Health in Adolescents Surviving Leukemia and Lymphoma

NCT07790913 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: OPTIMAL
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Lymphoblastic Leukemia in Remission; Hodgkin Lymphoma in Remission; Non-Hodgkin Lymphoma in Remission; Cancer Survivorship

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline and Week 24

Secondary Outcomes (2)

• Determine the tolerability of PHEN/TOP compared to SOC alone in adolescent and young adult patients with ALL or lymphoma and obesity.

  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.

  Week 24

Study Arms (2)

Treatment

EXPERIMENTAL

Participants receive phentermine-topiramate extended-release orally once daily for 24 weeks using dose escalation consistent with FDA-approved obesity treatment guidelines, plus health behavior and lifestyle counseling every 4 weeks.

Drug: Phentermine/Topiramate ER; Behavioral: Health Behavior and Lifestyle Counseling

Control

ACTIVE COMPARATOR

Participants receive standard health behavior and lifestyle counseling every 4 weeks for 24 weeks.

Behavioral: Health Behavior and Lifestyle Counseling

Interventions

Phentermine/Topiramate ER DRUG

Given orally once daily for 24 weeks using dose escalation consistent with FDA-approved obesity treatment guidelines.

Treatment

Health Behavior and Lifestyle Counseling BEHAVIORAL

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.

Control; Treatment

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 obesity (BMI ≥95th percentile for age- and sex- or BMI ≥30 kg/m2, whichever threshold is lower).
• Participant must provide written informed consent (if ≥18 years) or assent if 12-\<18 years and, if age \<18 a parent or legal guardian must provide consent and willingness to accompany subject to study visits.
• If female, participant must be using or willing to use adequate contraception defined as one of the following: double barrier methods, hormonal contraception plus single barrier method, tubal ligation or abstinence.

You may not qualify if:

• 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
• /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
• Heart rate ≥120 bpm on 3 separate occasions
• Treatment with any medication in the past 3 months with the intention to lose weight (semaglutide, tirzepatide, liraglutide, phentermine, topiramate, naltrexone hydrochloride (HCl)/bupropion HCl, lorcaserin).
• Participant currently uses, or has used in the past 3 months, other stimulants/sympathomimetic amines (for attention deficit/hyperactivity disorder (ADHD )or other indication).
• Participant has contraindication to phentermine/topiramate ER by package insert (glaucoma or increased intraocular pressure, untreated hyperthyroidism, recent monoamine oxidase inhibitor (MAOI) inhibitor use).
• Participant has a health condition that interferes with metabolism (untreated hypothyroidism, growth hormone deficiency with or without treatment, hypothalamic obesity).
• Participant is pregnant, planning to become pregnant or breast feeding.
• Participant has significant cardiac disease or ECG abnormality including:
• corrected QT interval (qTC) prolongation \>460msec, congenital heart disease with significant repair, cardiac arrhythmias requiring medication or pacemaker, heart failure requiring medication or uncontrolled hypertension or tachycardia.
• Participant has renal dysfunction (eGFR \<60 mL/min), bicarbonate \<18meq/L (labs may be repeated per investigator discretion), history of nephrolithiasis.
• Participant has clinically significant liver disease (AST or ALT \>3-times upper limit of normal, lab may be repeated per investigator discretion).
• Participant has epilepsy requiring anticonvulsants for seizure management.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Interventions

Qsymia

Study Officials

• Stephanie Dixon, MD, MPH

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Dixon, MD, MPH

CONTACT

888-226-4343; referralinfo@stjude.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2031
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

US (1)