Obesity Treatment Using Phentermine-Topiramate ER to Improve Metabolic Health in Adolescents Surviving Leukemia and Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Determine feasibility of obesity treatment with phentermine/extended-release topiramate (PHEN/TOP) compared to lifestyle alone (SOC) in patients 12-<25 years with ALL or lymphoma and obesity in maintenance therapy or up to 2 years off therapy.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Determine feasibility of obesity treatment with phentermine/extended-release topiramate (PHEN/TOP) compared to lifestyle alone (SOC) in patients 12-<25 years with ALL or lymphoma and obesity in maintenance therapy or up to 2 years off therapy.
时间窗: Baseline and Week 24
Feasibility will be defined as 1) participation rate (proportion of potentially eligible persons approached who enroll and are randomized) and 2) completion rate (proportion of participants randomized to the intervention arm completing study)
次要结局
- 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)