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

RecruitingObservational study

Who can join

All ages · All sexes

Full eligibility criteria
Inclusion Criteria:

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

Exclusion Criteria:

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

About the study

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).

Sponsor: St. Jude Children's Research Hospital · Participants: 200 · Started: Jun 26, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06646640

Locations in the U.S.

TennesseeSt. Jude Children's Research Hospital, Memphis

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.