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

National Cancer Institute (NCI) · NCT03000244

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 4–120 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
2000
US sites recruiting
1
Study start
April 26, 2017
Record last updated
October 16, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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....

Conditions: Cellular Immunotherapy, Adoptive; Genetic Therapy; Tissue Donors; Hematopoietic Stem Cell Transplantation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria
  • INCLUSION CRITERIA FOR PATIENT SUBJECTS:
  • Individuals who underwent HCT or received cellular or gene therapy for any indication (malignant or non-malignant) and are surviving one year or more from the date of therapy
  • Age >= 4 years
  • Ability of individual or individual s Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document
  • Individuals will need to have a primary physician within the US (primary care, oncologist, hematologist, etc.) that will provide continued comprehensive care for the duration of participation in the study. PI may allow for established medical providers to be located outside of the US.

EXCLUSION CRITERIA FOR PATIENT SUBJECTS

-Individuals with active disease relapse or new hematologic malignancy including post-transplant lymphoproliferative disorder (PTLD) are excluded from protocol enrollment.

INCLUSION CRITERIA FOR DONOR SUBJECTS

  • Related stem cell donors of patients meeting the above criteria as a donor of hematopoietic progenitor and stem cells or leukocytes
  • Age >= 4years
  • Ability of patient or patient s Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document

INCLUSION CRITERIA FOR PARENTS COMPLETING SURVEYS:

  • Parents/guardians of minors enrolled on the study who have undergone HCT
  • Willingness to complete surveys about the minor that underwent HCT

Recruiting US locations

  • National Institutes of Health Clinical Center

    Bethesda, MD 20892

    Site contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office · 888-624-1937

Study contacts (from the official record)

  • Danielle F Pinkiert, R.N. · (240) 858-7566 · danielle.pinkiert@nih.gov
  • Najla El Jurdi, M.D. · (240) 992-4033 · najla.eljurdi@nih.gov
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Long-Term Follow up of Patients Undergoing Hematopoietic Stem Cell… (NCT03000244) | Bored Studies