ClinicalTrials.gg
RecruitingNCT07634653STEP-ALLUpdated Aug 3, 2026

Strength Training Exercise in Pediatric Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (STEP-ALL)

An interventional study of Exercises in Leukemia, Acute Leukemia and Acute Lymphoid Leukemia, sponsored by UNC Lineberger Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to participants aged 6 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-03.

Primary conditionPrecursor Cell Lymphoblastic Leukemia-LymphomaRegistry: LeukemiaReclassifiedWhy we changed it
Registry
Leukemia — the first condition term the registry derived for this study.
ClinicalTrials.gg
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Why
  1. The study's listed conditions name Precursor Cell Lymphoblastic Leukemia-Lymphoma, a narrower term within Leukemia.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by UNC Lineberger Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started May 2026; still recruiting 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
6 Years and older
Sex
All
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Study summary

Acute lymphoblastic leukemia (ALL) is the most common cancer in children and, along with lymphoblastic lymphoma, represents the most common group of childhood lymphoid malignancies. Survival rates have improved over the years, but many children still experience long-term side effects from treatment. These can include tiredness, weak muscles, pain, nerve problems, difficulty moving, and other physical challenges. Many children with ALL are also overweight at diagnosis, and weight gain often continues during treatment. As a result, about half of childhood leukemia survivors have a BMI at or above the 85th percentile.

Treatment decisions are usually based on a child's symptoms and genetic risk factors. However, some risk factors such as physical activity can be modified. Exercise during treatment may help children feel better and may even improve survival. However, research on early symptom tracking and structured exercise during the first phase of chemotherapy is limited, uses different methods, and often does not include reliable patient-reported symptoms.

Effective exercise programs for children with ALL and lymphoblastic lymphoma need to consider the child's age, treatment side effects, motivation, family support, and ways to encourage long-term behavior change. Because children spend little time in the hospital during the induction phase, a mix of in-person and virtual sessions supported by real-time Zoom instruction can make it possible to offer safe and supervised exercise at home.

This study will use a guided exercise plan that includes tools to track sets, repetitions, intensity, warm-up time, and perceived exertion. These tools help with consistent monitoring and support both patients and caregivers throughout the program. Twenty children newly diagnosed with ALL or lymphoblastic lymphoma who receive standard 3-4 drug induction chemotherapy will be invited to participate. Our goal is to determine whether a 9-week hybrid exercise program, combined with weekly symptom check-ins, is practical and achievable in both hospital and home settings.

02

Conditions studied

  • Leukemia
  • Acute Leukemia
  • Acute Lymphoid Leukemia
  • Lymphoblastic Lymphoma
  • Acute Lymphoblastic Leukemia

Keywords

  • children
  • pediatric
  • weight gain
  • body mass index (BMI)
  • physical activity
  • Exercise
  • hybrid exercise program
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In context

Precursor Cell Lymphoblastic Leukemia-Lymphoma Reclassified

2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.

This study's planned enrollment of 40 is close to the median of 40 across 1,952 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 429 studies on the registry; 97 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 26 (79%) have results posted.

Compared within Precursor Cell Lymphoblastic Leukemia-Lymphoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Leukemia. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
6 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

All subjects must meet the following criteria:

  • Written 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

Exclusion Criteria for children:

  • Subjects must not be receiving any 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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Children with Acute lymphoblastic lymphoma or Acute lymphoblastic leukemia (ALL)

    Children diagnosed with Acute lymphoblastic leukemia (ALL) or acute lymphoblastic lymphoma who are medically able to exercise will be eligible to join the exercise program.

    Behavioral: Exercises

  • No intervention
    Caregivers of Children with Acute lymphoblastic lymphoma or Acute lymphoblastic leukemia (ALL)

    Caregivers of Children diagnosed with Acute lymphoblastic leukemia (ALL) or acute lymphoblastic lymphoma who are medically able to exercise will be eligible to join the exercise program.

Interventions

  • BehavioralExercises

    Participants will follow a strength-training routine using rubber resistance bands and their own body weight, completing exercises at least three times per week and recording the time spent on their study form. They will receive ongoing support through optional Zoom or phone check-ins, with the choice to join group online sessions or complete supervised sessions individually. The intervention begins Day 8 and continues through Consolidation Day 29.

06

What researchers measure

Primary outcomes

  1. Proportion of subjects completed exercise intervention

    The proportion of subjects who attend at least 16 of 24 total (3 per week) exercise sessions and complete ≥ 60% of the prescribed exercise plan.

    Time frame: Up to 9 weeks

Secondary outcomes

  1. Ability to capture weekly functional activity

    The proportion of subjects who have ≥ 75% of functional profile variables successfully collected in at least 75% (18 of 24) of sessions.

    Time frame: Up to 9 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Jun 2028, 25 months after the start.

Of 207 non-industry interventional studies with no phase under Precursor Cell Lymphoblastic Leukemia-Lymphoma, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 66. This study's planned 25 months is below that.

Counting every sponsor, half of 214 studies reached it within 32 months; a quarter within 12 and three quarters within 66.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 4, 2026
First posted
Jun 9, 2026
StartActual
May 1, 2026
Primary completionEst.
Jun 1, 2028
CompletionEst.
Jun 1, 2028
Last update
Aug 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07634653
Responsible party
Sponsor
First posted
Jun 9, 2026
Start date
May 1, 2026
Primary completion
Jun 1, 2028 (estimated)
Completion
Jun 1, 2028 (estimated)
Last update
Aug 3, 2026

Study contacts

Jessica Buddenbaum, MS
Contact
jessica_buddenbaum@med.unc.edu
919-966-4432
Juanita Cuffee
Contact
cuffee@med.unc.edu
919-216-0463
Thomas Alexander, MD, MPH
principal investigator · UNC Lineberger Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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