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New treatment option for Lymphoblastic Leukemia
Official title Exercise Training and NR Supplementation Trial to Improve Fitness in AYA HCT Survivors
ClinicalTrials.gov ID: NCT05194397
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 30
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility criteria
- 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...
- Subject's informed consent or parental/guardian permission (informed consent) and if appropriate, child assent
- Minimum weight of 24 kg
- 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
- 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...
- Parents/guardians or people 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...
- Current weight precludes safe completion of study procedures
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Philadelphia, Pennsylvania, United States
- Memphis, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Philadelphia, Pennsylvania, United States; Memphis, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.