Lymphoblastic LeukemiaPhase 2IAMFITNCT05194397
Exercise Training and NR Supplementation Trial to Improve Fitness in AYA HCT Survivors
A Phase 2 study testing Nicotinamide Riboside and Exercise Intervention in people with Lymphoblastic Leukemia and Cancer Survivors, run by Children's Hospital of Philadelphia at 3 sites in United States.
Trial summary
This will be a randomized, placebo-controlled trial with a 2x2 factorial design testing the effects of an NAD+ precursor (NR) and exercise on skeletal muscle quality and VO2max in AYA HCT survivors. The primary outcome is the change in muscle strength (isometric knee extension) from baseline to 16 weeks. Read more about this study
- Who is it for?
- Ages 10 to 30 years
- Conditions the study is for
- Lymphoblastic Leukemia, Cancer Survivors, Aplastic Anemia
- What is being tested?
- Nicotinamide Riboside and Exercise Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Feb 2023to 30 Jun 2026
- Phase
- Phase 2
- 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 10 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females, ages 10-30 years at enrollment
- Able to understand and speak English
- Diagnosis of leukemia (myeloid, lymphoid), aplastic anemia, bone marrow failure syndrome, or myelodysplastic syndrome requiring allogeneic HCT
- 6-48 months from allogeneic HCT
- Females must have a negative urine/serum pregnancy test and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.
- Subject's informed consent or parental/guardian permission (informed consent) and if appropriate, child assent
- Minimum weight of 24 kg
Who cannot join
- Known sensitivity to NR
- Concurrent use of any medications, including statins, likely to increase risk of NR toxicity
- Active malignancy, investigational agent(s) within 4 wks, or supraphysiological glucocorticoids at the baseline visit
- Currently meeting public health exercise guidelines
- Use of NAD+ precursors (supra-physiologic) within 4 weeks
- Hemoglobin < 10 g/dL
Show all 25Show fewer
- Platelets < 50K
- Diabetes Mellitus requiring insulin or insulin secretagogue
- HbA1C ≥ 8% or fasting glucose > 125 mg/dL; However if the participant is diabetic, both fasting glucose level and HbA1C must meet the criteria to be deemed eligible.
- Kidney disease (eGFR < 60 ml/min/1.73 m2)
- Liver disease Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) (ALT/AST > 3 x ULN)
- Limitations in physical function preventing exercise testing/training
- Unstable angina or history of acute myocardial infarction (<5 days of planned study procedures)
- Recurrent syncope
- Symptomatic severe aortic stenosis
- Uncontrolled arrhythmia causing symptoms
- Pulmonary embolus <3 months of study procedures
- Thrombosis of lower extremities
- Symptomatic moderate or severe persistent asthma based on Forced Expiratory Volume (FEV) from pre-HCT pulmonary function testing
- Room air desaturation at rest ≤85%
- Females: Pregnant or planning pregnancy
- Non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (e.g. infection, renal failure, thyrotoxicosis, >moderate Graft versus host disease (GVHD) resulting in physical or functional impairment)
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- For MRI procedure: Contraindications to MRI. Individuals will be screened to ensure they can safely complete the MRI. *participants who cannot complete the MRI will not be excluded from participation in the remainder of the study procedures if they meet those inclusion and exclusion criteria.
- Current weight precludes safe completion of study procedures
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Lanie Lindenfeld, MA, CCRP, 626-218-1150, llindenfeld@coh.org
Saro H Armenian, DO, MPH
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Sarah Terrell, MS, 901-595-4466, sarah.terrell@stjude.org
Kirsten K. Ness, PhD
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Susan Lee, 267-602-4603, leess@chop.edu
Kristin Wade, 267-398-5761, wadekl@chop.edu
About this study
Official title: Intensive Tailored Exercise Training With NAD+ Precursor Supplementation to Improve Muscle Mass and Fitness in Adolescent and Young Adult Hematopoietic Cell Transplant Survivors
This will be a randomized, placebo-controlled trial with a 2x2 factorial design testing the effects of an NAD+ precursor (NR) and exercise on skeletal muscle quality and VO2max in AYA HCT survivors.
The primary outcome is the change in muscle strength (isometric knee extension) from baseline to 16 weeks. Key secondary outcomes are the change in muscle strength (ankle plantarflexion) from baseline to 16 weeks, the change in grip strength from baseline to 16 weeks, the change in lower extremity muscle mass from baseline to 16 weeks, the change in muscle OXPHOS capacity from baseline to 16 weeks, and the change in aerobic capacity (VO2 max) from baseline to 16 weeks.
Read the detailed description
Adolescents and young adults (AYAs) who undergo hematopoietic cell transplantation (HCT) are at an especially high risk of developing sarcopenia (loss of skeletal muscle mass), which occurs earlier than would be expected from advancing age alone. This is important as not only it doubles their risk for non-relapse mortality, but it also leads to premature cardiovascular disease. The investigators propose a mechanistic randomized controlled trial of home-based remotely supervised exercise (aerobic and resistance) training and supplementation with nicotinamide riboside, a precursor of NAD+, a metabolite that is critical for muscle metabolism, in AYA survivors of HCT. The findings will lay the critical groundwork for future trials to prevent or mitigate the myriad downstream adverse effects of low muscle mass in AYA HCT survivors.
- Conditions
- Lymphoblastic Leukemia, Cancer Survivors, Aplastic Anemia, Myelodysplastic Syndromes, Myeloid Leukemia
- Being tested
- Nicotinamide Riboside, Placebo, Exercise Intervention
- Keywords
- Sarcopenia, NAD+, Exercise Intervention, OXPHOS Capacity, VO2 Max, Adolescent young adults, Cancer Survivors, Hematopoietic Stem Cell Transplantation (HCT)
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Anemia, Aplastic, Myelodysplastic Syndromes, Leukemia, Myeloid, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide RibosideDietary supplement
Investigators will use (Good Manufacturing Process) GMP-grade 300 mg capsules of the dietary supplement nicotinamide riboside (ChromaDex, Irvine CA).
NR is distributed by ChromaDex, Inc., Irvine, CA. NR is available as 300 mg capsules.
The dietary supplement will be re-labeled by the Hospital of the University of Pennsylvania (HUP) Investigational Drug Service according to FDA regulations, including subject and physician name and NR or Placebo 300 mg capsules.
PlaceboDietary supplement
The matched placebo will contain the same excipients without the active supplement and is generally recognized as safe. The placebo will be covered in an identical capsule (NR will be covered in the same capsule)
The exercise program consists of at-home training sessions and will include aerobic and strengthening components designed to progress persons gradually to 150-300 minutes of the equivalent of moderate aerobic activity, and twice weekly strengthening over 16 weeks. For aerobic training, the eventual intensity and duration goal (adapted for each person as necessary) will be for persons to train at 70-80% of peak 2MSPT heart rate 20-45 minutes 3-5 days/week. For resistance exercises the goal will be a load/weight that results in fatigue after 3 sets of 10-12 repetitions on 8-10 exercises 2 days/week.
| Study group | Role | What they receive |
|---|---|---|
| Nicotinamide Riboside (NR) | Experimental | Investigators will use Good Manufacturing Process (GMP)-grade 300 mg capsules of the dietary supplement nicotinamide riboside (ChromaDex, Irvine CA). Investigators dose based on body weight, and monitor for adverse effects (AEs).
For individuals with weight > 72 kg: 900 mg po qd x 16 wks.
For individuals with weight > 48 kg and ≤ 72 kg: 600 mg po qd x 16 wks.
For individuals with weight 24 ≤ 48 kg: 300 mg po qd x 16 wks. Receives: Dietary Supplement: Nicotinamide Riboside |
| Placebo | Placebo comparator | Matched placebo will contain the same excipients without the active supplement and is generally recognized as safe. The placebo will be covered in an identical capsule (NR will be covered in the same capsule). Doses of placebo will match the body weight schema for dosing of NR. Investigators dose based on body weight, and monitor for adverse effects (AEs).
For individuals with weight > 72 kg: 900 mg po qd x 16 wks.
For individuals with weight > 48 kg and ≤ 72 kg: 600 mg po qd x 16 wks.
For individuals with weight 24 ≤ 48 kg: 300 mg po qd x 16 wks. Receives: Dietary Supplement: Placebo |
| Exercise Intervention and NR | Experimental | The exercise program consists of at-home training sessions including: aerobic and strengthening components designed to progress persons gradually to 150-300 minutes of the equivalent of moderate aerobic activity, and twice weekly strength training exercises.
Participants in this arm will receive both the Exercise Intervention and the NR. Receives: Dietary Supplement: Nicotinamide Riboside; Other: Exercise Intervention |
| Exercise Intervention and Placebo | Experimental | The exercise program consists of at-home training sessions including: aerobic and strengthening components designed to progress persons gradually to 150-300 minutes of the equivalent of moderate aerobic activity, and twice weekly strength training exercises.
Participants in this arm will receive both the Exercise Intervention and the Placebo Receives: Dietary Supplement: Placebo; Other: Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within participant changes in muscle strength (Isometric knee extension, Z-score)
Muscle Strength will be assessed by completion of isometric contractions using a Biodex dynamometer.
Measured: Baseline to 16 Weeks
Secondary outcomes (5)
Within participant change in muscle strength (Ankle Plantarflexion)
Muscle Strength will be assessed by completion of isometric contractions using a Biodex dynamometer.
Measured: Baseline to 16 Weeks
Within participant change in grip strength (Hand Grip Dynamometry)
Grip Strength will be assessed using a hand grip dynamometry device.
Measured: Baseline to 16 Weeks
Within participant changes in muscle mass (lower leg lean muscle mass by DXA)
Muscle mass will be assessed by completion of whole body DXA scanning.
Measured: Baseline to 16 Weeks
Within participant changes in post-exercise oxidative phosphorylation capacity (OXPHOS).
OXPHOS capacity will be assessed by completion of non-invasive MRI scanning using creatine chemical exchange saturation transfer (CrCEST).
Measured: Baseline to 16 Weeks
Within participant change in aerobic capacity (VO2 max, Maximal Oxygen Uptake on Cardiopulmonary Exercise Testing).
VO2 Max will be assessed by completion of an incremental cardio-pulmonary Exercise Stress Test (EST) on an upright leg cycle ergometer
Measured: Baseline to 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start23 Feb 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomized, placebo-controlled trial with a 2x2 factorial design testing the effects of an NAD+ precursor (NR) and exercise.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), City of Hope Medical Center, St. Jude Children's Research Hospital, National Cancer Institute (NCI), University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Sogol Mostoufi-Moab, MD, MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194397
- Sponsor's protocol ID
- 20-017320
- Other IDs
- 1R01CA254955-01A1
- Acronym
- IAMFIT
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2021
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: No identifiable data will be used for future study without first obtaining IRB approval. The investigator will obtain a fully executed data use agreement between the provider (the PI) of the data and any recipient researchers \[(including others at CHOP) before sharing a limited dataset (or the data will only be provided to users under a fully executed data use (or data sharing) agreement approved by the Children's Hospital of Philadelphia (CHOP) Institutional Review Board (IRB)\]. The execution of the agreement will require approval by the Children's Hospital of Philadelphia (CHOP) Institutional Review Board (IRB) or a demonstration of IRB exemption per institutional policy.
Publications
Song M, Armenian SH, Bhandari R, Lee K, Ness K, Putt M, Lindenfeld L, Manoukian S, Wade K, Dedio A, Guzman T, Hampton I, Lin K, Baur J, McCormack S, Mostoufi-Moab S. Exercise training and NR supplementation to improve muscle mass and fitness in adolescent and young adult hematopoietic cell transplant survivors: a randomized controlled trial 1. BMC Cancer. 2022 Jul 19;22(1):795. doi: 10.1186/s12885-022-09845-1.
PubMed 35854224
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Tailored Exercise Training With NAD+ Precursor Supplementation to Improve Muscle Mass and Fitness in Adolescent and Young Adult Hematopoietic Cell Transplant Survivors
- ClinicalTrials.gov ID
- NCT05194397
- Acronym / sponsor ID
- IAMFIT / 20-017320
- Conditions
- Lymphoblastic Leukemia, Cancer Survivors, Aplastic Anemia, Myelodysplastic Syndromes, Myeloid Leukemia
- Keywords
- Sarcopenia, NAD+, Exercise Intervention, OXPHOS Capacity, VO2 Max, Adolescent young adults, Cancer Survivors, Hematopoietic Stem Cell Transplantation (HCT)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), City of Hope Medical Center, St. Jude Children's Research Hospital, National Cancer Institute (NCI), University of Pennsylvania
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 18 Jan 2022 (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.
This will be a randomized, placebo-controlled trial with a 2x2 factorial design testing the effects of an NAD+ precursor (NR) and exercise on skeletal muscle quality and VO2max in AYA HCT survivors.
The primary outcome is the change in muscle strength (isometric knee extension) from baseline to 16 weeks. Key secondary outcomes are the change in muscle strength (ankle plantarflexion) from baseline to 16 weeks, the change in grip strength from baseline to 16 weeks, the change in lower extremity muscle mass from baseline to 16 weeks, the change in muscle OXPHOS capacity from baseline to 16 weeks, and the change in aerobic capacity (VO2 max) from baseline to 16 weeks.
Detailed description
Adolescents and young adults (AYAs) who undergo hematopoietic cell transplantation (HCT) are at an especially high risk of developing sarcopenia (loss of skeletal muscle mass), which occurs earlier than would be expected from advancing age alone. This is important as not only it doubles their risk for non-relapse mortality, but it also leads to premature cardiovascular disease. The investigators propose a mechanistic randomized controlled trial of home-based remotely supervised exercise (aerobic and resistance) training and supplementation with nicotinamide riboside, a precursor of NAD+, a metabolite that is critical for muscle metabolism, in AYA survivors of HCT. The findings will lay the critical groundwork for future trials to prevent or mitigate the myriad downstream adverse effects of low muscle mass in AYA HCT survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized, placebo-controlled trial with a 2x2 factorial design testing the effects of an NAD+ precursor (NR) and exercise.
| Arm | Type | Receives |
|---|---|---|
| Nicotinamide Riboside (NR) | Experimental | Dietary Supplement: Nicotinamide RibosideInvestigators will use Good Manufacturing Process (GMP)-grade 300 mg capsules of the dietary supplement nicotinamide riboside (ChromaDex, Irvine CA). Investigators dose based on body weight, and monitor for adverse effects (AEs). For individuals with weight > 72 kg: 900 mg po qd x 16 wks. For individuals with weight > 48 kg and ≤ 72 kg: 600 mg po qd x 16 wks. For individuals with weight 24 ≤ 48 kg: 300 mg po qd x 16 wks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMatched placebo will contain the same excipients without the active supplement and is generally recognized as safe. The placebo will be covered in an identical capsule (NR will be covered in the same capsule). Doses of placebo will match the body weight schema for dosing of NR. Investigators dose based on body weight, and monitor for adverse effects (AEs). For individuals with weight > 72 kg: 900 mg po qd x 16 wks. For individuals with weight > 48 kg and ≤ 72 kg: 600 mg po qd x 16 wks. For individuals with weight 24 ≤ 48 kg: 300 mg po qd x 16 wks. |
| Exercise Intervention and NR | Experimental | Dietary Supplement: Nicotinamide Riboside, Other: Exercise InterventionThe exercise program consists of at-home training sessions including: aerobic and strengthening components designed to progress persons gradually to 150-300 minutes of the equivalent of moderate aerobic activity, and twice weekly strength training exercises. Participants in this arm will receive both the Exercise Intervention and the NR. |
| Exercise Intervention and Placebo | Experimental | Dietary Supplement: Placebo, Other: Exercise InterventionThe exercise program consists of at-home training sessions including: aerobic and strengthening components designed to progress persons gradually to 150-300 minutes of the equivalent of moderate aerobic activity, and twice weekly strength training exercises. Participants in this arm will receive both the Exercise Intervention and the Placebo |
Who may qualify
- Ages
- 10 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Males and females, ages 10-30 years at enrollment
- Able to understand and speak English
- Diagnosis of leukemia (myeloid, lymphoid), aplastic anemia, bone marrow failure syndrome, or myelodysplastic syndrome requiring allogeneic HCT
- 6-48 months from allogeneic HCT
- Females must have a negative urine/serum pregnancy test and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.
Key exclusion criteria (25 listed)
- Known sensitivity to NR
- Concurrent use of any medications, including statins, likely to increase risk of NR toxicity
- Active malignancy, investigational agent(s) within 4 wks, or supraphysiological glucocorticoids at the baseline visit
- Currently meeting public health exercise guidelines
- Use of NAD+ precursors (supra-physiologic) within 4 weeks
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 |
|---|---|---|
| Nicotinamide RibosideInvestigators will use (Good Manufacturing Process) GMP-grade 300 mg capsules of the dietary supplement nicotinamide riboside (ChromaDex, Irvine CA). NR is distributed by ChromaDex, Inc., Irvine, CA. NR is available as 300 mg capsules. The dietary supplement will be re-labeled by the Hospital of the University of Pennsylvania (HUP) Investigational Drug Service according to FDA regulations, including subject and physician name and NR or Placebo 300 mg capsules. | Dietary supplement | Exercise Intervention and NR, Nicotinamide Riboside (NR) |
| PlaceboThe matched placebo will contain the same excipients without the active supplement and is generally recognized as safe. The placebo will be covered in an identical capsule (NR will be covered in the same capsule) | Dietary supplement | Exercise Intervention and Placebo, Placebo |
| Exercise InterventionThe exercise program consists of at-home training sessions and will include aerobic and strengthening components designed to progress persons gradually to 150-300 minutes of the equivalent of moderate aerobic activity, and twice weekly strengthening over 16 weeks. For aerobic training, the eventual intensity and duration goal (adapted for each person as necessary) will be for persons to train at 70-80% of peak 2MSPT heart rate 20-45 minutes 3-5 days/week. For resistance exercises the goal will be a load/weight that results in fatigue after 3 sets of 10-12 repetitions on 8-10 exercises 2 days/week. | Other | Exercise Intervention and NR, Exercise Intervention and Placebo |
Primary outcome
Within participant changes in muscle strength (Isometric knee extension, Z-score)
Time frame: Baseline to 16 Weeks
Muscle Strength will be assessed by completion of isometric contractions using a Biodex dynamometer.
5 secondary outcomes
Within participant change in muscle strength (Ankle Plantarflexion)
Time frame: Baseline to 16 Weeks
Within participant change in grip strength (Hand Grip Dynamometry)
Time frame: Baseline to 16 Weeks
Within participant changes in muscle mass (lower leg lean muscle mass by DXA)
Time frame: Baseline to 16 Weeks
Within participant changes in post-exercise oxidative phosphorylation capacity (OXPHOS).
Time frame: Baseline to 16 Weeks
Within participant change in aerobic capacity (VO2 max, Maximal Oxygen Uptake on Cardiopulmonary Exercise Testing).
Time frame: Baseline to 16 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 4 Dec 2025.
- Derived from this study: PubMed 35854224Song M, Armenian SH, Bhandari R, Lee K, Ness K, Putt M, Lindenfeld L, Manoukian S, Wade K, Dedio A, Guzman T, Hampton I, Lin K, Baur J, McCormack S, Mostoufi-Moab S. Exercise training and NR supplementation to improve muscle mass and fitness in adolescent and young adult hematopoietic cell transplant survivors: a randomized controlled trial 1. BMC Cancer. 2022 Jul 19;22(1):795. doi: 10.1186/s12885-022-09845-1.
- Individual participant dataSharing planned: Yes. No identifiable data will be used for future study without first obtaining IRB approval. The investigator will obtain a fully executed data use agreement between the provider (the PI) of the data and any recipient researchers [(including others at CHOP) before sharing a limited dataset (or the data will only be provided to users under a fully executed data use (or data sharing) agreement approved by the Children's Hospital of Philadelphia (CHOP) Institutional Review Board (IRB)]. The execution of the agreement will require approval by the Children's Hospital of Philadelphia (CHOP) Institutional Review Board (IRB) or a demonstration of IRB exemption per institutional policy.
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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.
Sogol Mostoufi-Moab, MD, MSCE principal investigator
Children's Hospital of Philadelphia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotinamide Riboside and Exercise Intervention in people with Lymphoblastic Leukemia and Cancer Survivors, run by Children's Hospital of Philadelphia at 3 sites 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 7 inclusion and 25 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 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Katherine Cambareri, MPH (445-942-7801, cambarerik@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Within participant changes in muscle strength (Isometric knee extension, Z-score) (time frame: Baseline to 16 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05194397, which also lists 1 linked publication.
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 4 Dec 2025.