LeukemiaSTEP-ALLNCT07634653
Strength Training Exercise in Pediatric Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (STEP-ALL)
A study testing Exercises in people with Leukemia and Acute Leukemia, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Leukemia, Acute Leukemia, Acute Lymphoid Leukemia
- What is being tested?
- Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Juanita Cuffee, 919-966-0017, cuffee@med.unc.edu
Jessica Buddenbaum, MS, jessica_buddenbaum@med.unc.edu
About this study
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.
Read more
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.
- Conditions
- Leukemia, Acute Leukemia, Acute Lymphoid Leukemia, Lymphoblastic Lymphoma, Acute Lymphoblastic Leukemia
- Being tested
- Exercises
- Keywords
- children, pediatric, weight gain, body mass index (BMI), physical activity, Exercise, hybrid exercise program
- Medical subject headings
- Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Weight Gain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Children with Acute lymphoblastic lymphoma or Acute lymphoblastic leukemia (ALL) | Experimental | 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. Receives: Behavioral: Exercises |
| Caregivers of Children with Acute lymphoblastic lymphoma or Acute lymphoblastic leukemia (ALL) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 May 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Alexander, MD, MPH, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634653
- Sponsor's protocol ID
- LCCC2541
- Acronym
- STEP-ALL
- Status last verified
- Jul 2026
- First submitted
- 4 Jun 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength Training Exercise in Pediatric Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (STEP-ALL)
- ClinicalTrials.gov ID
- NCT07634653
- Acronym / sponsor ID
- STEP-ALL / LCCC2541
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with Acute lymphoblastic lymphoma or Acute lymphoblastic leukemia (ALL) | Experimental | Behavioral: ExercisesChildren diagnosed with Acute lymphoblastic leukemia (ALL) or acute lymphoblastic lymphoma who are medically able to exercise will be eligible to join the exercise program. |
| Caregivers of Children with Acute lymphoblastic lymphoma or Acute lymphoblastic leukemia (ALL) | No intervention | –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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExercisesParticipants 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. | Behavioural | Children with Acute lymphoblastic lymphoma or Acute lymphoblastic leukemia (ALL) |
Primary outcome
Proportion of subjects completed exercise intervention
Time frame: Up to 9 weeks
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.
1 secondary outcome
Ability to capture weekly functional activity
Time frame: Up to 9 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Alexander, MD, MPH principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises in people with Leukemia and Acute Leukemia, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Buddenbaum, MS (919-966-4432, jessica_buddenbaum@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects completed exercise intervention (time frame: Up to 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.