This early phase I trial investigates the side effects of nicotinamide riboside supplementation in improving engraftment in patients who underwent donor hematopoietic stem cell transplant. Engraftment is defined as the process during which transplanted stem cells begin to grow in recipient bone marrow and produce new white blood cells, red blood cells, and platelets. It is estimated to take about 14-24 days for donor cells to engraft after infusion. Nicotinamide riboside may help decrease the time to engraftment, thereby decrease the risk of complications and improve long-term health status.
Additional locations may be listed on ClinicalTrials.gov for NCT04332341.
Locations matching your search criteria
United States
Ohio
Cleveland
Case Comprehensive Cancer CenterStatus: Active
Contact: Ronald Michael Sobecks
Phone: 216-445-4626
PRIMARY OBJECTIVE:
I. Evaluate safety and tolerability of nicotinamide riboside (NR) supplementation peri-hematopoietic cell transplantation (HCT) from day -14 to day +7, +14, or +21.
SECONDARY OBJECTIVE:
I. Evaluate neutrophil and platelet recovery after HCT.
CORRELATIVE OBJECTIVES:
I. Nicotinamide adenine dinucleotide positive (NAD+) levels and their metabolites via mass spectrometry in mononuclear cells.
II. Suspension culture/colony forming unit assay of mononuclear cells.
III. CD45+CD34+/CD38- flow cytometry.
IV. Serum niacin level by micro titer plate assay.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP A: Patients receive standard of care. Patients undergo blood sample collection throughout the study. Additionally, patients may optionally undergo bone marrow biopsy post transplant.
GROUP B: Patients receive NR orally (PO) twice daily (BID) from day -14 to either day 7, 14, or 21 in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Additionally, patients may optionally undergo bone marrow biopsy post transplant.
Patients are followed up at day 60 and 100 after transplant.
Trial PhasePhase O
Trial Typesupportive care
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorRonald Michael Sobecks