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

Recruiting now

Conditions studied: Hemoglobin Disorder

In brief

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).

Key facts

Study ID

NCT06646640

Run by

St. Jude Children's Research Hospital

People needed

200

Starts

2025-06-26

Expected to finish

2050-01-01

Last updated by the study team

2025-08-07

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Receipt, or planned receipt, of an allogeneic HSCT or infusion of genetically modified autologous cells for hemoglobin disorders within 15 years prior to enrollment

You may not qualify if…

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

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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