Acute Lymphoblastic Leukemia in RemissionPhase 2NCT07790913
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
A Phase 2 study testing Phentermine/Topiramate ER and Health Behavior and Lifestyle Counseling in people with Acute Lymphoblastic Leukemia in Remission and Hodgkin Lymphoma in Remission, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 24 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission, Non-Hodgkin Lymphoma in Remission
- What is being tested?
- Phentermine/Topiramate ER and Health Behavior and Lifestyle Counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Aug 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
- 140/90 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).
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- 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.
- Participant has any history of eating disorder or laxative abuse.
- Participant has a history of substance abuse.
- Prior bariatric surgery.
- Participant has a history of bipolar disorder, psychosis, prior suicide attempt or current moderate severity depression (PHQ-9 of 10 or more), report of suicidal ideation in the past 3 months, or self-injurious behavior in the past 3 months.
- Participant has relapsed disease or need for transplant.
- Participant is unable to swallow pills.
- Participant has a genetic or other congenital condition involving global delays (i.e.Trisomy 21, cerebral palsy) or requires a surrogate for over age 18 years.
- Use of any investigational medication for treatment of cancer in a clinical study within the past 30 days (must have completed all investigational treatments and corticosteroids and be receiving only outpatient, non- investigational maintenance chemotherapy).
- Non-English speaking participant (or primary guardian/caregiver for those <18 years).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Stephanie Dixon, MD, MPH, 888-226-4343, referralinfo@stjude.org
8662785833, referralinfo@stjude.org
About this study
Official title: Obesity Treatment Using Phentermine-Topiramate ER to Improve Metabolic Health in Adolescents and Young Adults Surviving Leukemia and Lymphoma
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.
Read the detailed description
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:
- Determine the feasibility of obesity treatment using combination phentermine and extended-release topiramate plus health behavior and lifestyle counselling (PHEN/TOP) compared to health behavior and lifestyle counselling alone as standard of care (SOC) in adolescent and young adult patients with ALL or lymphoma and obesity who have achieved remission and are completing outpatient, maintenance therapy or in the first 2 years of survivorship.
Secondary Objective:
- Determine the tolerability of PHEN/TOP compared to SOC alone in adolescent and young adult patients with ALL or lymphoma and obesity.
- 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.
- Conditions
- Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission, Non-Hodgkin Lymphoma in Remission, Cancer Survivorship
- Being tested
- Phentermine/Topiramate ER, Health Behavior and Lifestyle Counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phentermine/Topiramate ERDrug
Given orally once daily for 24 weeks using dose escalation consistent with FDA-approved obesity treatment guidelines.
Health Behavior and Lifestyle CounselingBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Phentermine/Topiramate ER; Behavioral: 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. Receives: Behavioral: Health Behavior and Lifestyle Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
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.
Measured: 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.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study startDec 2026 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia in RemissionStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Dixon, MD, MPH, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790913
- Sponsor's protocol ID
- OPTIMAL
- Status last verified
- Nov 2026
- First submitted
- 24 Aug 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity Treatment Using Phentermine-Topiramate ER to Improve Metabolic Health in Adolescents and Young Adults Surviving Leukemia and Lymphoma
- ClinicalTrials.gov ID
- NCT07790913
- Acronym / sponsor ID
- OPTIMAL
- Conditions
- Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission, Non-Hodgkin Lymphoma in Remission, Cancer Survivorship
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Determine the feasibility of obesity treatment using combination phentermine and extended-release topiramate plus health behavior and lifestyle counselling (PHEN/TOP) compared to health behavior and lifestyle counselling alone as standard of care (SOC) in adolescent and young adult patients with ALL or lymphoma and obesity who have achieved remission and are completing outpatient, maintenance therapy or in the first 2 years of survivorship.
Secondary Objective:
- Determine the tolerability of PHEN/TOP compared to SOC alone in adolescent and young adult patients with ALL or lymphoma and obesity.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| phentermine topiramate extended release (PHEN/TOP) + Health Behavior and Lifestyle Counseling | Experimental | Drug: Phentermine/Topiramate ER, Behavioral: Health Behavior and Lifestyle CounselingParticipants 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. |
| Health Behavior and Lifestyle Counseling Alone (SOC [Standard of Care]) | Active comparator | Behavioral: Health Behavior and Lifestyle CounselingParticipants receive standard health behavior and lifestyle counseling every 4 weeks for 24 weeks. |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (24 listed)
- 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
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phentermine/Topiramate ERGiven orally once daily for 24 weeks using dose escalation consistent with FDA-approved obesity treatment guidelines. | Drug | phentermine topiramate extended release (PHEN/TOP) + Health Behavior and Lifestyle Counseling |
| Health Behavior and Lifestyle CounselingDietary, 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. | Behavioural | Health Behavior and Lifestyle Counseling Alone (SOC [Standard of Care]), phentermine topiramate extended release (PHEN/TOP) + Health Behavior and Lifestyle Counseling |
Primary outcome
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
Participation measured by acceptance of the intervention evidenced by the participation rate (proportion of potentially eligible persons who were approached who enroll on study).
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.
Time frame: Baseline and Week 24
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.
2 secondary outcomes
Determine the tolerability of PHEN/TOP compared to SOC alone in adolescent and young adult patients with ALL or lymphoma and obesity.
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.
Time frame: Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie Dixon, MD, MPH principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Phentermine/Topiramate ER and Health Behavior and Lifestyle Counseling in people with Acute Lymphoblastic Leukemia in Remission and Hodgkin Lymphoma in Remission, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Dixon, MD, MPH (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.