Long-Term Follow up of Patients Undergoing Hematopoietic Stem Cell Transplantation, Cellular Therapy, or Gene Therapy

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03000244
Status
Recruiting
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Conditions

  • Cellular Immunotherapy, Adoptive
  • Genetic Therapy
  • Hematopoietic Stem Cell Transplantation
  • Tissue Donors

Eligibility Criteria

Sex
ALL
Age
4 Years - 120 Years
Healthy Volunteers
Accepted

Study Details

Background: People who have had an allogeneic hematopoietic stem cell transplant (HCT), cellular therapy (CT), or gene therapy (GT) have bone marrow or an immune system that is damaged. They get stem cells from a donor who is a relative. Researchers want to study stem cell donors and recipients to learn about the long-term effects of HCT, CT, or GT. They want to learn how the stem cells change and how to improve their ability to fight cancer. Objective: To provide long-term follow-up care for people who underwent or will undergo HCT, CT, or GT. To collect data, blood, and tissue samples to learn about late complications after HCT, CT, or GT. Eligibility: Adults age 18 and older who will undergo HCT or underwent HCT, Cellular Therapy (CT), or Gene Therapy (GT) and are surviving one year or more from the date of therapy. The stem cell donors for these recipients are also needed. Design: Recipients will have 1 visit each year. They will have a physical exam. They will answer questions about their medical history and health. They will receive screening and surveillance testing. They will complete brief questionnaires. Recipients will have blood tests. They may have tissue biopsies or specimens (such as tissue in their cheek or skin or bone marrow biopsy). Recipients will give their current address and phone number, and the same data for one or two other people, who can get in contact with them. After the first visit at the clinic, some recipients may see a doctor close to home to get the necessary information and send it to NIH. Donors will come to the clinic for 1 visit. They will answer questions about their medical history. Blood samples will be taken.

Key Dates

First listed
Dec 22, 2016
Start date
Apr 26, 2017
Status verified
Jul 2026
Primary completion
Aug 12, 2050
Completion
Aug 12, 2050

Study Design

Enrollment
2,000 participants (estimated)

Arms

  • Arm: 1/Patients
    Patients who underwent hematopoietic stem cell transplant or received cellular therapy or gene therapy for any indication (malignant or non-malignant).
  • Arm: 2/Donors
    Related stem cell donors of those in Patients cohort.
  • Arm: 3/Parents of patients
    Parents/guardians of minors enrolled in cohort 1

Primary Outcome Measure

Basic characteristics of the patient population [ Time Frame: at death ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
888-624-1937

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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