Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT07790913
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
12 Years - 24 Years
Healthy Volunteers
Not accepted

Interventions

  • Phentermine/Topiramate ER — DRUG
    Given orally once daily for 24 weeks using dose escalation consistent with FDA-approved obesity treatment guidelines.
  • 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.

Study Details

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.

Key Dates

First listed
Aug 27, 2026
Start date
Oct 31, 2026
Status verified
Sep 2026
Primary completion
Aug 31, 2030
Completion
Aug 31, 2031

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: phentermine topiramate extended release (PHEN/TOP) + Health Behavior and Lifestyle Counseling
    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.
  • Active Comparator: Health Behavior and Lifestyle Counseling Alone (SOC [Standard of Care])
    Participants receive standard health behavior and lifestyle counseling every 4 weeks for 24 weeks.

Primary Outcome Measure

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. [ Time Frame: Baseline and Week 24 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105
Stephanie Dixon, MD, MPH
[email protected]
888-226-4343
[email protected]
8662785833
Stephanie Dixon, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
St. Jude Children's Research Hospital· Memphis, TN

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