A Two-Step Approach to Bone Marrow Transplant Using Cells From A Partially-Matched Relative (NCT00429143) | Clinical Trial Compass
CompletedPhase 1/2
A Two-Step Approach to Bone Marrow Transplant Using Cells From A Partially-Matched Relative
United States27 participantsStarted 2006-01
Plain-language summary
The purpose of this study is to develop a way of treating patients who do not have a completely matched family donor or a readily available unrelated donor with bone marrow transplant by using a partially-matched family donor. Patients receiving this type of transplant will receive chemotherapy and/or radiation to treat their disease. They will also receive their donor's cells in 2 parts. During the first part, the donor's lymphocytes will be exposed to one of the chemotherapy agents to help the patient become tolerant to the lymphocytes. In the second part of the transplant, the patient will receive their donor's stem cells to help recover their peripheral blood counts and establish long-term engraftment. The hypothesis of this study is that in partially-matched allogeneic transplant, there is a defined number of donor T-cells that can be treated and given to the recipient to avoid post-transplant infection without causing severe graft-versus-host disease.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Any patient with a hematologic or oncologic diagnosis in which allogeneic HSCT is thought to be beneficial, and in whom front-line therapy has already been applied.
✓. Patients must have a related donor who is either a one, two or three out of six antigen mismatch at the HLA-A;B;DR loci.
✓. Patients without a well-matched unrelated donor or those who have a disease status that precludes a wait for an identified unrelated donor.
✓. Patients must adequate organ function:
✓. Performance status \> 60% (Karnofsky)
✓. Patients must be willing to use contraception if they have childbearing potential
✓. Able to give informed consent
Exclusion criteria
✕. An eligible HLA-identical sibling donor.
✕. Performance status \< 60% (Karnosfsky)
✕
What they're measuring
1
Overall Survival of Participants
Timeframe: 6 months
2
Optimal Dose of CD3+ Donor Lymphocytes (T-cells) for Consistent Engraftment Without GVHD
Timeframe: 6 months
Trial details
NCT IDNCT00429143
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University