Clinical trial Recruiting at 1 site Interventional Ages 6 and up

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 typeInterventional
Ages6 Years and up
SexAll
Enrollment40 (estimated)
SponsorUNC Lineberger Comprehensive Cancer Center
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Chapel Hill, North Carolina)
StatusRecruiting
StartedMay 1, 2026
Main results expectedJune 1, 2028
Study endsJune 1, 2028
Registry record updatedAugust 3, 2026
Trial IDNCT07634653 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

  • University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center
    Chapel Hill, North Carolina, United States
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.