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Infusion of Donor Dendritic Cells and Donor Lymphocytes in Patients With Relapsed Hematologic Malignancies After Allogenic Transplant

Phase 1
18 Years
Not Enrolling
Hematologic Malignancy

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Trial Information

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.

Inclusion Criteria:

- Patients with hematologic malignancies who have relapsed after related or unrelated
donor hematopoietic stem cell transplantation (e.g. CML, AML, ALL, MDS, NHL, HD, CLL,

- At least two months following hematopoietic stem cell transplantation

- Patients off any systemic immunosuppressive medication for treatment or prevention of
GVHD for minimum of 2 weeks prior to initiation of therapy

- 18 years of age or older

- ECOG performance status 0-2

- Donor medically fit to undergo leukapheresis procedure

Exclusion Criteria:

- Relapsed CML in chronic phase

- Prior donor lymphocyte infusion or other immunotherapy treatment within 8 weeks of

- Clinically significant and active autoimmune disease in donor or patient

- Evidence of active grade II-IV acute GVHD or active extensive chronic GVHD

- Uncontrolled infection

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Edwin Alyea, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

July 2003

Completion Date:

July 2009

Related Keywords:

  • Hematologic Malignancy
  • DC
  • DLI
  • graft vs. host disease
  • GVHD
  • Neoplasms
  • Hematologic Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115