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

NCT00476177 | Completed Phase 1 DMC

• 1 other identifier: 02-003
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hematologic Malignancy

Keywords

DC; DLI; graft vs. host disease; GVHD

Outcome Measures

Primary Outcomes (1)

• 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.

  4 years

Secondary Outcomes (2)

• To assess clinical response after infusions of donor derived DC and donor lymphocytes

• To assess the immunologic impact of infusions of donor derived DC and donor lymphocytes.

Interventions

Infusion of donor dendritic cells BIOLOGICAL

Given in the outpatient setting

Infusion of donor lymphocytes BIOLOGICAL

Given in outpatient setting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Graft vs Host Disease

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Study Officials

• Edwin Alyea, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2007
• First Posted: May 21, 2007
• Study Start: July 1, 2003
• Primary Completion: August 1, 2007
• Study Completion: July 1, 2009
• Last Updated: March 29, 2012

Record last verified: 2012-03

Locations

US (2)