Strength Training for Kids with Acute Lymphoblastic Leukemia and Lymphoblastic L lymphoma
Official title: Strength Training Exercise in Pediatric Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (STEP-ALL)
Run by UNC Lineberger Comprehensive Cancer Center · NCT07634653 · Data updated 2026-11-12
Researchers are testing a structured strength-training program for children and teens recently diagnosed with ALL or lymphoblastic lymphoma to see if it helps with weight gain and physical function during treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Status | Recruiting |
| Started | May 1, 2026 |
| Main results expected | June 1, 2028 |
| Study ends | June 1, 2028 |
| Registry record updated | August 3, 2026 |
| Trial ID | NCT07634653 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children and young people aged 6 to 21 years who are newly diagnosed with B-cell or T-cell ALL or lymphoblastic lymphoma and are starting induction chemotherapy.
✕Probably not a fit
Patients not able to participate safely in an exercise program due to other health issues or ongoing investigational therapies may see no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study enrolls children and young people aged 6 to 21 who are newly diagnosed with B-cell or T-cell ALL or lymphoblastic lymphoma to participate in a supervised exercise program. The approach focuses on strength training during the early phase of chemotherapy, aiming to improve physical abilities and manage treatment-related side effects. The trial will monitor safety, adherence, and potential benefits on BMI and muscle strength, with caregiver participation optional. No comparison group is described in the available details, and the study is led by UNC Lineberger Comprehensive Cancer Center with institutions at UNC Chapel Hill. Enrollment considerations include informed consent/assent and eligibility criteria related to concurrent therapies and health status.
Why it matters
Potential benefit: If successful, the program could improve physical function and help manage weight during treatment for pediatric ALL and lymphoblastic lymphoma.
How similar studies have gone: Prior research in pediatric cancer has shown exercise can be feasible and beneficial for physical function, but data during early chemotherapy for ALL and lymphoblastic lymphoma remain limited and this trial explores a focused approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria for children: All subjects must meet the following criteria: * Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. OR Written assent and parental/legal guardian consent. * Age \>= 6 and \< =21 years at the time of diagnosis. * Newly- diagnosed with one of the following diseases: B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma Exclusion Criteria for children: * Subjects must not be receiving any investigational or additional anti-cancer medicines during induction. * Significant concurrent disease, illness, or psychiatric disorder or social issue that would compromise subject safety or adherence to the protocol treatment or procedures, interfere with consent, study participation, follow-up, or interpretation of the study results. Optional caregiver participation: Inclusion Criteria :All caregivers must meet the following criteria * Written informed consent to participate in the caregiver interviews. * The caregiver must be a parent or legal guardian ≥ 18 years old, and their child must be \<18 years
Where it's running
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University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Thomas Alexander, MD, MPH — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Jessica Buddenbaum, MS
- Email: jessica_buddenbaum@med.unc.edu
- Phone: 919-966-4432
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.