Infusion of Donor Dendritic Cells and Donor Lymphocytes in Patients With Relapsed Hematologic Malignancies After Allogenic Transplant
- Since we are looking for the highest dose of donor dendritic cells that can be
administered safely with DLI patients after allogeneic stem cell transplant, not
everyone who participates in this study will be receiving the same number of dendritic
- The study procedure can be divided into 3 phases: 1) Pre-infusion evaluation, 2) Cell
collections and infusions, 3) Follow-up after infusions.
- Pre-infusion evaluation: Routine blood tests will be performed on both the participant
and donor. The participant will undergo a bone marrow aspirate and biopsy if this has
not been recently performed. During this time, additional standard blood tests and/or
radiology tests may be done to fully determine the extent of the cancer.
- Cell Collections: About 2-3 weeks before the infusion date, the 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 a portion
will be used to cultivate dendritic cells, and the remaining lymphocytes will be set
aside for the DLI. If the number of cells collected at the first leukopheresis is
insufficient, the donor will undergo a second leukopheresis procedure 7-10 days later.
- Infusions: We plan to administer the dendritic cells and donor lymphocytes separately
in the outpatient clinic. The dendritic cells will be given first, followed by the DLI
one to two days later.
- Follow-up after infusions: After completion of both the donor DC and DLI, participants
will be followed closely for the development of side effects and response. They will
be evaluated at least once a week, and routine blood tests and physical examination to
assess for graft vs. host disease (GvHD) or other side effects will be performed.
Additional blood tests will be done after 3, 6, and 10 weeks. At 10 weeks after the
lymphocyte infusion, bone marrow aspirate and biopsy will be performed to assess the
disease as well as the percentage of bone marrow cells that are derived from the donor.
Additional restaging studies will also be performed at 10 weeks.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose of allogeneic DC in combination with DLI in patents with a relapsed hematologic malignancy following allogeneic hematopoietic stem cell transplantation.
Edwin Alyea, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|