Who is eligible for clinical trial NCT07790913?

Participants must meet the protocol's inclusion criteria for Acute Lymphoblastic Leukemia in Remission. The stated age range is 12 Years to 24 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT07790913 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-24

Obesity Treatment Using Phentermine-Topiramate ER to Improve Metabolic Health in Adolescents Surviving Leukemia and Lymphoma (NCT07790913)

🟡 Not Yet Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: St. Jude Children's Research Hospital

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (24 items).

Location: St. Jude Children's Research Hospital — Memphis, Tennessee

Age range: 12 Years to 24 Years

🧪 Interventions in This Study

Phentermine/Topiramate ER (DRUG)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

St. Jude Children's Research Hospital — Memphis, Tennessee

📞 Contact the Study Coordinator

Phone: (888) 226-4343

Email: referralinfo@stjude.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗