Donor Dendritic Cells And Donor Lymphocytes in Patients With Relapsed Hematologic Malignancies After Allogeneic Transplant

Completed · Phase 1

Conditions studied: Hematologic Malignancy

In brief

The purpose of this study is to test the safety of adding donor dendritic cells to donor lymphocyte infusions, and to determine the type and severity of any side effects associated with this addition. Previously patients with hematologic malignancies who relapsed after transplant have been given infusions of donor white blood cells (donor lymphocyte infusion, DLI) as a way to boost their immune function and fight disease. Although DLI has led to cancer regression in some patients, the overall response rate using DLI alone is low, and unfortunately, rarely lasting. Researchers have discovered a new subset of blood cells, called dendritic cells (DC), which are crucial partners to lymphocytes in generating an immune response. We believe that the infusion of DC together with DLI may improve the ability of the donor lymphocytes to recognize and kill cancer cells.

Key facts

Study ID

NCT00476177

Run by

Dana-Farber Cancer Institute

People needed

25

Starts

2003-07-01

Expected to finish

2009-07-01

Last updated by the study team

2012-03-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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, MM)
• 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

You may not qualify if…

• Relapsed CML in chronic phase
• Prior donor lymphocyte infusion or other immunotherapy treatment within 8 weeks of enrollment
• 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

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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