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

NCT07790913 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-08-27

No results posted yet for this study

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

Interventions

DRUG

Phentermine/Topiramate ER

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

BEHAVIORAL

Health 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.

Sponsors & Collaborators

Principal Investigators

  • Stephanie Dixon, MD, MPH · St. Jude Children's Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2030-08-31
Completion
2031-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07790913 on ClinicalTrials.gov