Donor Lymphocyte Infusion After Blood or Bone Marrow Transplant for High-Risk Blood Cancers

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05327023

Provider View

This study is exploring whether giving an infusion of donor white blood cells early after a blood or bone marrow transplant can help reduce the risk of cancer returning in patients with high-risk blood cancers.

Patient Parameters

Program Overview

This study is investigating if giving an infusion of donor lymphocytes (a type of white blood cell) early after a blood or bone marrow transplant can help lower the chance of relapse in patients with high-risk blood cancers like leukemia and lymphoma. The study involves adults aged 18-65 who have these cancers and are at high risk of relapse. Healthy relatives aged 12 and older can also participate as donors. Participants will undergo various tests and stay at the NIH hospital for about 4 weeks, receiving chemotherapy and a transplant, followed by donor white blood cells. They will need to stay near the hospital for at least 100 days after the transplant and will have follow-up visits for 5 years. Donors will have 2-3 visits to provide samples for research.

Description

This study focuses on patients with high-risk blood cancers who have undergone a blood or bone marrow transplant. The goal is to see if an early infusion of donor lymphocytes can help prevent the cancer from coming back. Participants will receive chemotherapy and a transplant, followed by an infusion of donor white blood cells. They will stay at the NIH hospital for about 4 weeks and must remain nearby for at least 100 days after the transplant. Follow-up visits will continue for 5 years to monitor their health and the effectiveness of the treatment. Healthy relatives can participate as donors, providing blood, bone marrow, and other samples for research.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18-65 with high-risk blood cancers like leukemia, lymphoma, myelodysplastic syndrome, or multiple myeloma.
  • Must have a suitable donor who is a relative and matches certain genetic markers.
  • Must be in good overall health with adequate heart, lung, and kidney function.
  • Women of childbearing potential must agree to use effective birth control and have a negative pregnancy test before joining the study.

Donor Criteria:

  • Healthy relatives aged 12 and older willing to donate blood, bone marrow, and stool samples for research.

Exclusion Criteria

  • Currently receiving other experimental treatments.
  • Have had previous high-dose chemotherapy for a transplant.
  • Have active non-blood-related cancers that are not treatable.
  • Have uncontrolled health issues that make it unsafe to proceed with the transplant.
  • Women who are breastfeeding.

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