Study of Nicotinamide Riboside Supplementation in Allogeneic Hematopoietic Cell Transplantation

Официальное название

A Pilot Study of Nicotinamide Riboside Supplementation in Allogeneic Hematopoietic Cell Transplantation

Обзор

The purpose of this study is to find a safe and tolerable way to improve engraftment after transplant. Research studies have shown that adding nicotinamide riboside to donor cells has the potential to increase blood stem cell numbers and potentially decrease the time to engraftment. Also, nicotinamide riboside, TRU NIAGEN (the study drug) is a type of vitamin B supplement that the general public can get without a prescription and is well tolerated.

Подробное описание

This is a single-center, pilot feasibility study of NR supplementation in allogeneic (donor) HCT in which the study team is seeking to obtain preliminary data on any beneficial effect of increasing NAD+ levels in-vivo to facilitate engraftment. Engraftment is defined as the process during which transplanted stem cells begin to grow in the bone marrow and produce new white blood cells, red blood cells, and platelets. It takes about 14 to 24 days for donor cells to engraft after infusion, and the time between which blood counts fall to the time when they recover is a very critical period. Transfusions are frequently required to prevent bleeding and antibiotics are needed to prevent infections during this critical time period. Shortening the time of engraftment decreases these risks and can improve long-term health status.

The primary objectives of this study is to evaluate safety and tolerability of NR supplementation

The secondary objective of this study is to evaluate neutrophil and platelet recovery after HCT

Вмешательства

• Препарат Nicotinamide riboside (NR)
  Nicotinamide riboside, PO, 500mgtwice daily for 21, 28, and 35 days

Первичные конечные точки

• Percent of participants who receive >75% of scheduled doses. [Срок оценки: day +7]
• Percent of participants who receive >75% of scheduled doses. [Срок оценки: day +14]
• Percent of participants who receive >75% of scheduled doses. [Срок оценки: day +21]
• Percent of participants experiencing a CTCAE 5.0 grade 3 or higher related to the study drug [Срок оценки: day +7]
• Percent of participants experiencing a CTCAE 5.0 grade 3 or higher related to the study drug [Срок оценки: day +14]
• Percent of participants experiencing a CTCAE 5.0 grade 3 or higher related to the study drug [Срок оценки: day +21]

Вторичные конечные точки (2)

• Median days to neutrophil recovery after HCT [Срок оценки: Up to 100 days from start of treatment]
• Median days to platelet recovery after HCT [Срок оценки: Up to 100 days from start of treatment]

Критерии участия

Критерии включения

• All disease indications for allogeneic hematopoietic cell transplantation except for myelofibrosis.
• Subject must meet program eligibility criteria\* for myeloablative conditioning alloHCT and plan to undergo myeloablative conditioning.
• HLA-identical related donor or unrelated human donor source with bone marrow graft.
• Subjects must provide a written informed consent.

Критерии исключения

• History of allergy or intolerance to NR precursor compounds, including niacin or nicotinamide
• Pregnant or breastfeeding women are excluded from this study since allogeneic HCT is a strict contraindication.
• Subjects with uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland

Идентификаторы

NCT: NCT04332341 · CASE2Z20

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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