A Phase 2 interventional study of Phentermine/Topiramate ER and Health Behavior and Lifestyle Counseling in Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission and Non-Hodgkin Lymphoma in Remission, sponsored by St. Jude Children's Research Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 12 Years to 24 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by St. Jude Children's Research Hospital · Phase 2, Interventional, and Treatment
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.
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 are completing outpatient therapy or are within approximately 2 years of therapy completion.
Participants assigned to the intervention arm will receive daily phentermine-topiramate ER with dose escalation according to FDA-approved obesity treatment guidelines in addition to counseling every 4 weeks. Participants assigned to the control arm will receive counseling alone. The intervention period lasts 24 weeks, followed by an observational follow-up visit at week 52 to assess durability of response.
Researchers will assess study participation and completion rates, medication safety and tolerability, and changes in body weight and BMI. The study will also explore effects on body composition, heart and metabolic health, physical activity, eating habits, cognitive function, and quality of life.
Primary Objective:
Secondary Objective:
1,383 studies on the registry are indexed under Hodgkin Disease; 163 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 1,095 interventional studies indexed under Hodgkin Disease.
Browse Hodgkin Disease studies →St. Jude Children's Research Hospital is the lead sponsor of 440 studies on the registry; 102 are open to participants now.
Of its 61 completed or terminated interventional studies of FDA-regulated products, 37 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participant has poorly controlled hypertensions: current blood pressure
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participants receive standard health behavior and lifestyle counseling every 4 weeks for 24 weeks.
Behavioral: Health Behavior and Lifestyle Counseling
Drug pages: Phentermine · Topiramate
Given orally once daily for 24 weeks using dose escalation consistent with FDA-approved obesity treatment guidelines.
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.
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).
Time frame: 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.
Time frame: Baseline and Week 24
Determine the tolerability of PHEN/TOP compared to SOC alone in adolescent and young adult patients with ALL or lymphoma and obesity.
Tolerability measured by frequency of adverse events (AEs, using Common Terminology Criteria for Adverse Events \[CTCAE\]) and proportion of participants who discontinue PHEN/TOP due to AEs. We will also report the proportion of patients who complete study on a therapeutic dose as top-dose and mid-dose PHEN/TOP.
Time frame: 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.
Primary measure of efficacy will be the proportion of participants in each arm who achieve at least 5% BMI reduction from baseline to week 24.
Time frame: Week 24
Start is estimated for Dec 2026; primary completion for Aug 2030, 44 months later.
Of 183 non-industry phase 2 interventional studies under Hodgkin Disease, half reached primary completion within 80 months of starting (the median), counting those still running; a quarter within 48 and three quarters within 115. This study's planned 44 months is below that.
Counting every sponsor, half of 206 studies reached it within 75 months; a quarter within 42 and three quarters within 111.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Dec 2026, on Nov 6, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Phentermine · Topiramate
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