[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653663":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":31,"studyPopulation":24,"armGroups":32,"interventions":45,"overallOfficials":56,"centralContacts":60,"locations":65,"responsibleParty":83,"collaborators":24,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":24,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":24,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":24,"overallStatus":107,"whyStopped":24,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"St. Jude Children's Research Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":24},[9,13],{"measure":10,"description":11,"timeFrame":12},"Determine feasibility of obesity treatment with phentermine\u002Ftopiramate ER plus health behavior and lifestyle counseling (PHEN\u002FTOP) 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",{"measure":14,"description":15,"timeFrame":12},"Determine the feasibility of completing obesity treatment with phentermine\u002Ftopiramate ER plus health behavior and lifestyle counseling (PHEN\u002FTOP) 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\u002FTOP arm completing the treatment phase of the study, defined by completion of the week 24 study visit irrespective of adherence to pharmacotherapy.",[17,21],{"measure":18,"description":19,"timeFrame":20},"Determine the tolerability of PHEN\u002FTOP 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\u002FTOP 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\u002FTOP.","Week 24",{"measure":22,"description":23,"timeFrame":20},"Estimate preliminary efficacy of PHEN\u002FTOP 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.",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":24,"primaryPurpose":28,"observationalModel":24,"timePerspective":24,"maskingInfo":29},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":30,"maskingDescription":24,"whoMasked":24},"NONE","Survivors of childhood leukemia and lymphoma are at increased risk for obesity and cardiometabolic complications during treatment and early survivorship.\n\nThe 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.\n\nThe 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.\n\nParticipants 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.\n\nResearchers 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.\n\nPrimary Objective:\n\n* Determine the feasibility of obesity treatment using combination phentermine and extended-release topiramate plus health behavior and lifestyle counselling (PHEN\u002FTOP) 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.\n\nSecondary Objective:\n\n* Determine the tolerability of PHEN\u002FTOP compared to SOC alone in adolescent and young adult patients with ALL or lymphoma and obesity.\n* Estimate preliminary efficacy of PHEN\u002FTOP compared to SOC for change in body mass index (BMI) in adolescent and young adult patients with ALL or lymphoma and obesity.",[33,40],{"label":34,"type":35,"description":36,"interventionNames":37},"phentermine topiramate extended release (PHEN\u002FTOP) + 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.",[38,39],"Drug: Phentermine\u002FTopiramate ER","Behavioral: Health Behavior and Lifestyle Counseling",{"label":41,"type":42,"description":43,"interventionNames":44},"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.",[39],[46,51],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":24},"DRUG","Phentermine\u002FTopiramate ER","Given orally once daily for 24 weeks using dose escalation consistent with FDA-approved obesity treatment guidelines.",[34],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":24},"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\u002Fday deficit and reinforces healthy lifestyle behaviors.",[41,34],[57],{"name":58,"affiliation":5,"role":59},"Stephanie Dixon, MD, MPH","PRINCIPAL_INVESTIGATOR",[61],{"name":58,"role":62,"phone":63,"phoneExt":24,"email":64},"CONTACT","888-226-4343","referralinfo@stjude.org",[66],{"facility":5,"status":24,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Memphis","Tennessee","38105","United States","US",{"type":73,"coordinates":74},"Point",[75,76],-90.04898,35.14953,{"lat":76,"lon":75},[79,80,82],{"name":58,"role":62,"phone":63,"phoneExt":24,"email":64},{"name":24,"role":62,"phone":81,"phoneExt":24,"email":64},"8662785833",{"name":58,"role":59,"phone":24,"phoneExt":24,"email":24},{"type":84,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100653663","phase-2-obesity-treatment-using-phentermine-topiramate-er-to-improve-metabolic-health-in-adolescents-surviving-leukemia-and-lymphoma-100653663",false,"NCT07790913","Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma","Obesity Treatment Using Phentermine-Topiramate ER to Improve Metabolic Health in Adolescents and Young Adults Surviving Leukemia and Lymphoma","Inclusion Criteria:\n\n* Participant has acute lymphoblastic leukemia (ALL), Hodgkin lymphoma, or non-Hodgkin lymphoma.\n* 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).\n* Participant will have completed all cycles of therapy that include corticosteroids at the time of study\n* Participant is age ≥12 and \\\u003C25-yrs at study entry\n* Participant has obesity (BMI ≥95th percentile for age- and sex- or BMI ≥30 kg\u002Fm2, whichever threshold is lower).\n* Participant must provide written informed consent (if ≥18 years) or assent if 12-\\\u003C18 years and, if age \\\u003C18 a parent or legal guardian must provide consent and willingness to accompany subject to study visits.\n* 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.\n\nExclusion Criteria:\n\n* Participant has had recent, ongoing weight loss (≥5 kg in past 3-months).\n* 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.\n* Participant has poorly controlled hypertensions: current blood pressure\n\n  * 140\u002F90 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\n* Heart rate ≥120 bpm on 3 separate occasions\n* Treatment with any medication in the past 3 months with the intention to lose weight (semaglutide, tirzepatide, liraglutide, phentermine, topiramate, naltrexone hydrochloride (HCl)\u002Fbupropion HCl, lorcaserin).\n* Participant currently uses, or has used in the past 3 months, other stimulants\u002Fsympathomimetic amines (for attention deficit\u002Fhyperactivity disorder (ADHD )or other indication).\n* Participant has contraindication to phentermine\u002Ftopiramate ER by package insert (glaucoma or increased intraocular pressure, untreated hyperthyroidism, recent monoamine oxidase inhibitor (MAOI) inhibitor use).\n* Participant has a health condition that interferes with metabolism (untreated hypothyroidism, growth hormone deficiency with or without treatment, hypothalamic obesity).\n* Participant is pregnant, planning to become pregnant or breast feeding.\n* Participant has significant cardiac disease or ECG abnormality including:\n\ncorrected 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.\n\n* Participant has renal dysfunction (eGFR \\\u003C60 mL\u002Fmin), bicarbonate \\\u003C18meq\u002FL (labs may be repeated per investigator discretion), history of nephrolithiasis.\n* Participant has clinically significant liver disease (AST or ALT \\>3-times upper limit of normal, lab may be repeated per investigator discretion).\n* Participant has epilepsy requiring anticonvulsants for seizure management.\n* Participant has any history of eating disorder or laxative abuse.\n* Participant has a history of substance abuse.\n* Prior bariatric surgery.\n* 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.\n* Participant has relapsed disease or need for transplant.\n* Participant is unable to swallow pills.\n* 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.\n* 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).\n* Non-English speaking participant (or primary guardian\u002Fcaregiver for those \\\u003C18 years).","ALL","12 Years","24 Years",{"count":96,"type":97},100,"ESTIMATED","INTERVENTIONAL",[100],"PHASE2","This study is evaluating whether a weight-loss medication (PHEN\u002FTOP) 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\u002FTOP plus counseling or counseling alone for 24 weeks and are followed for up to 52 weeks.",[103,104,105,106],"Acute Lymphoblastic Leukemia in Remission","Hodgkin Lymphoma in Remission","Non-Hodgkin Lymphoma in Remission","Cancer Survivorship","NOT_YET_RECRUITING","2026-09-18",{"date":110,"type":111},"2026-09-23","ACTUAL",{"date":113,"type":97},"2026-10",{"date":115,"type":97},"2031-08",{"name":5,"class":6},1]