Trials Sponsors Conditions Drugs Pricing

Conditions

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

Outcome Measures

Primary Outcomes (2)

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).
Baseline and Week 24
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.
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)

phentermine topiramate extended release (PHEN/TOP) + Health Behavior and Lifestyle Counseling

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 ERBehavioral: Health Behavior and Lifestyle Counseling

Health Behavior and Lifestyle Counseling Alone (SOC [Standard of Care])

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 ERDrug

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

phentermine topiramate extended release (PHEN/TOP) + Health Behavior and Lifestyle Counseling

Health Behavior and Lifestyle CounselingBehavioral

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.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Phentermine/Topiramate ER
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age12 Years - 24 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (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).

Sponsors & Collaborators

St. Jude Children's Research Hospital
Otherlead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Stephanie Dixon, MD, MPHCONTACT888-226-4343 referralinfo@stjude.org

CONTACT8662785833 referralinfo@stjude.org

Stephanie Dixon, MD, MPHPRINCIPAL INVESTIGATOR

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

October 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

August 2030

Estimated

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.
+9 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

phentermine topiramate extended release (PHEN/TOP) + Health Behavior and Lifestyle Counseling

Health Behavior and Lifestyle Counseling Alone (SOC [Standard of Care])

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

phentermine topiramate extended release (PHEN/TOP) + Health Behavior and Lifestyle Counseling

Health Behavior and Lifestyle Counseling Alone (SOC [Standard of Care])

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations