Donor Dendritic Cells And Donor Lymphocytes in Patients With Relapsed Hematologic Malignancies After Allogeneic Transplant
This study has been completed.
Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Edwin P. Alyea, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00476177
First received: May 18, 2007
Last updated: March 28, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hematologic Malignancy |
Biological: Infusion of donor dendritic cells Biological: Infusion of donor lymphocytes |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Infusion of Donor Dendritic Cells and Donor Lymphocytes in Patients With Relapsed Hematologic Malignancies After Allogenic Transplant |
Resource links provided by NLM:
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
- 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. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To assess clinical response after infusions of donor derived DC and donor lymphocytes [ Time Frame: TBD ] [ Designated as safety issue: No ]
- To assess the immunologic impact of infusions of donor derived DC and donor lymphocytes. [ Time Frame: TBD ] [ Designated as safety issue: No ]
| Enrollment: | 25 |
| Study Start Date: | July 2003 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Biological: Infusion of donor dendritic cells
Given in the outpatient setting
Biological: Infusion of donor lymphocytes
Given in outpatient setting
- 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 cells.
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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, 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476177
Locations
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Investigators
| Principal Investigator: | Edwin Alyea, MD | Dana-Farber Cancer Institute |
More Information
No publications provided
| Responsible Party: | Edwin P. Alyea, MD, Principal Investigator, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00476177 History of Changes |
| Other Study ID Numbers: | 02-003 |
| Study First Received: | May 18, 2007 |
| Last Updated: | March 28, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Dana-Farber Cancer Institute:
|
DC DLI graft vs. host disease GVHD |
Additional relevant MeSH terms:
|
Neoplasms Hematologic Neoplasms Neoplasms by Site Hematologic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013