Infusion of Donor Lymphocytes Depleted of CD25+ Regulatory T-cells in Patients With Relapsed Hematologic Malignancies After Matched Allogeneic Hematopoietic Stem Cell Transplantation
- The original marrow/stem cell donor will undergo one or two white blood cell collection
procedures called leukopheresis. The cells collected from the first leukopheresis will
be sent to the laboratory where the amount of white blood cells collected will be
measured. If the number of cells collected at the first leukopheresis is not enough,
the donor will have a second leukopheresis procedure.
- Once enough lymphocytes are collected from the donor, the CliniMACS CD25 Reagent System
device will reduce the number of CD25+ Tregs. The CD25+ depleted donor lymphocytes
will then be infused to the participant intravenously. Participants will be observed
for about one hour after the infusion.
- One, two, four and eight weeks after the DLI, participants will return to the clinic
for follow-up visits. At each visit a physical exam, questions about the participants
general health, and blood tests will be performed.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the feasibility of using the ClinMACS CD25 Reagent device to engineer a DLI product outlined in the protocol
John Koreth, MBBS, DPhil
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|