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NR Supplementation for Bone Marrow Transplant Engraftment Improvement

Phase < 1

Recruiting

Led By Navneet Majhail, MD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

HLA-identical related donor or unrelated human donor source with bone marrow graft

Subject must meet program eligibility criteria for myeloablative conditioning alloHCT and plan to undergo myeloablative conditioning

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 100 days from start of treatment

Awards & highlights

Study Summary

This trialis testing a vitamin B supplement to improve engraftment after transplant. It has potential to increase stem cell numbers and reduce time to engraftment.

Who is the study for?

This trial is for individuals who are eligible for a bone marrow transplant with myeloablative conditioning and have an HLA-identical donor. It's not suitable for pregnant or breastfeeding women, those with uncontrolled illnesses or psychiatric conditions that could affect compliance, or anyone allergic to NR compounds like niacin.Check my eligibility

What is being tested?

The study is testing the addition of Nicotinamide Riboside (NR), a vitamin B supplement, to donor cells in bone marrow transplants. The goal is to see if it can safely increase stem cell numbers and speed up engraftment after the transplant.See study design

What are the potential side effects?

While NR is generally well tolerated by the public as an over-the-counter supplement, potential side effects specific to its use in this setting aren't detailed but may include typical reactions related to vitamin supplements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a matching donor for my bone marrow transplant.

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I am eligible and planning to undergo a bone marrow transplant with intensive preparation.

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I am eligible for a stem cell transplant, but I do not have myelofibrosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 100 days from start of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 100 days from start of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 100 days from start of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent of participants experiencing a CTCAE 5.0 grade 3 or higher related to the study drug

Percent of participants who receive >75% of scheduled doses.

Secondary outcome measures

Median days to neutrophil recovery after HCT

Median days to platelet recovery after HCT

Trial Design

1Treatment groups

Experimental Treatment

Group I: Nicotinamide riboside (NR)Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nicotinamide riboside (NR)

2016

N/A

~40

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor

452 Previous Clinical Trials

31,890 Total Patients Enrolled

Navneet Majhail, MDPrincipal InvestigatorCleveland Clinic, Case Comprehensive Cancer Center

2 Previous Clinical Trials

81 Total Patients Enrolled

Ronald Sobecks, MDPrincipal InvestigatorCleveland Clinic, Case Comprehensive Cancer Center

Media Library

Nicotinamide riboside (NR) Clinical Trial Eligibility Overview. Trial Name: NCT04332341 — Phase < 1

Bone Marrow Transplant Research Study Groups: Nicotinamide riboside (NR)

Bone Marrow Transplant Clinical Trial 2023: Nicotinamide riboside (NR) Highlights & Side Effects. Trial Name: NCT04332341 — Phase < 1

Nicotinamide riboside (NR) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04332341 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please provide details of past experiments related to Nicotinamide riboside (NR)?

"Currently, 15 trials revolving around Nicotinamide riboside (NR) are underway with 1 of them being in its final phase. Across 19 different medical centres across the US, patients can partake in clinical studies relating to Nicotinamide riboside (NR), particularly concentrated in Iowa City, Iowa."

Answered by AI

Are there still opportunities for enrollment in this experiment?

"According to information posted on clinicaltrials.gov, this trial is currently searching for participants. The project was first advertised in May 2020 and modified as recently October 2022."

Answered by AI

What is the capacity of participants for this clinical research?

"Affirmative. The information available on clinicaltrials.gov verifies that this medical investigation, which was first listed on May 19th 2020, is actively recruiting persons of interest. 20 participants are needed to be collected from 1 healthcare facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Nicotinamide Riboside Supplementation in Allogeneic Hematopoietic Cell Transplantation

2020. "Study of Nicotinamide Riboside Supplementation in Allogeneic Hematopoietic Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04332341.