Recruiting

Observational Study

Sponsor:

National Cancer Institute (NCI)

Code:

NCT03000244

Conditions

Cellular Immunotherapy, Adoptive

Genetic Therapy

Tissue Donors

Hematopoietic Stem Cell Transplantation

Eligibility Criteria

Sex: All

Age: 4 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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

Study ID

NCT03000244

Start date

Apr 26, 2017

Status verified date

Aug 20, 2026

Completion date

Aug 12, 2050

Anticipated

Primary completion date

Aug 12, 2050

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 70+

Healthy Volunteers: Accepted

  • 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

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

1/Patients

Patients who underwent hematopoietic stem cell transplant or received cellular therapy or gene therapy for any indication (malignant or non-malignant).

2/Donors

Related stem cell donors of those in Patients cohort.

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 and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

888-624-1937

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Aug 31, 2026

Last verified

Aug 20, 2026

Keywords

  • Cellular Therapy
  • Gene Therapy
  • Natural History
  • HCT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-08-31.