Actively Recruiting

All Genders
NCT06646640

Long Term Follow-Up Study for Individuals With Hemoglobin Disorders After Hematopoietic Cell Transplant or Gene Therapy

Led by St. Jude Children's Research Hospital · Updated on 2025-08-07

200

Participants Needed

1

Research Sites

1279 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a prospective, longitudinal, non-therapeutic study which includes routine assessment for long-term effects, as per FDA guidelines after receipt of an allogeneic HCT or autologous genetically modified cellular products for hemoglobin disorders. Primary objective: \- To provide long term follow up, for individuals with hemoglobin disorders undergoing allogeneic hematopoietic stem cell transplantation (HCT) or receipt of an autologous genetically modified cellular product to treat their hemoglobinopathy. For individuals receiving a genetically modified cellular product, this long term follow up study is in accordance with the guidelines provided by the Food and Drug Administration (FDA).

CONDITIONS

Official Title

Long Term Follow-Up Study for Individuals With Hemoglobin Disorders After Hematopoietic Cell Transplant or Gene Therapy

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Receipt, or planned receipt, of an allogeneic HSCT or infusion of genetically modified autologous cells for hemoglobin disorders within 15 years prior to enrollment
Not Eligible

You will not qualify if you...

  • Inability or unwillingness of research participant and/or legal guardian/ representative to provide written informed consent.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

St. Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

Actively Recruiting

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Research Team

A

Akshay Sharma, MD

CONTACT

N

Neha Das Gupta, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Long Term Follow-Up Study for Individuals With Hemoglobin Disorders After Hematopoietic Cell Transplant or Gene Therapy | DecenTrialz