Not yet recruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 24 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 24 weeks, 52 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a weight-loss drug called phentermine-topiramate ER (PHEN/TOP) with healthy lifestyle counseling in people ages 12–24 with obesity whose leukemia or lymphoma is in remission, meaning signs of cancer have gone away. It checks safety, side effects, and weight loss. Participants are assigned by chance to the drug plus counseling or counseling alone for 24 weeks, with follow-up for up to 52 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have acute lymphoblastic leukemia (ALL), Hodgkin lymphoma, or non-Hodgkin lymphoma in remission.
  • Be finishing standard outpatient maintenance treatment, with no more planned hospital treatment, OR have finished cancer treatment within the past 27 months.
  • Have finished all treatment cycles that include corticosteroids, a type of steroid medicine.
  • Be at least 12 years old but younger than 25.
  • Have obesity: a BMI at or above the 95th percentile for age and sex, or at least 30, whichever cutoff is lower. BMI compares weight with height.
  • Give written consent if 18 or older. Those under 18 must agree, and a parent or guardian must give consent and agree to attend study visits.
  • If female, use or agree to use approved pregnancy prevention: two barrier methods, hormonal birth control plus a barrier method, tied fallopian tubes, or no sex.

Who can't join

  • Have lost at least 5 kg (about 11 pounds) in the past 3 months and are still losing weight; used weight-loss drugs or stimulant medicines in the past 3 months; or had weight-loss surgery.
  • Have diabetes treated with medicine or an A1c blood sugar test of 6.5% or higher. Past steroid-related diabetes may be allowed if it has ended, insulin stopped at least 3 months ago, and no more steroids are planned.
  • Have poorly controlled blood pressure, a blood pressure medicine change not stable for 3 months, a pulse of at least 120 on three checks, or serious heart disease or an abnormal heart tracing.
  • Have glaucoma or high eye pressure, untreated overactive thyroid, recent use of MAOI antidepressants, or a condition affecting how the body uses energy, such as untreated low thyroid, growth hormone deficiency, or obesity linked to the hypothalamus in the brain.
  • Are pregnant, planning pregnancy, or breastfeeding; have poor kidney function, low blood bicarbonate, past kidney stones, significant liver disease, or epilepsy needing seizure medicine.
  • Have a history of an eating disorder, laxative misuse, substance abuse, bipolar disorder, psychosis, or a suicide attempt; have current moderate depression; or had suicidal thoughts or self-harm in the past 3 months.
  • Have cancer that has returned, need a transplant, or used an experimental cancer drug within the past 30 days.
  • Cannot swallow pills; have a genetic or birth condition causing broad developmental delays; need someone else to make decisions for you if over 18; or do not speak English. For those under 18, the main guardian or caregiver must also speak English.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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). * 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).

Study sites (1)

TN