Infusion of Donor Lymphocytes Depleted of CD25+ Regulatory T-Cells in Patients With Relapsed Hematologic Malignancies - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Miltenyi Biotec
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00675831

Purpose

The purpose of this research study is to evaluate the safety and efficacy of cell depletion in a donor lymphocyte infusion (DLI) product with the use of the CliniMACS machine. Previously, patients with hematologic malignancies who have relapsed after transplant have been given infusions of donor white blood cells calsed donor lymphocyte infusion (DLI) as a way to boost their immune function and fight cancer. Information from other research studies suggests that lowering the number of a certain type of white blood cell called CD25+ Tregs in the DLI may allow for a greater effect. In this research study, we are looking for the appropriate dose of DLI depleted of the CD25+ Treg white blood cells that can be given safely.

Condition	Intervention	Phase
Hematologic Malignancies	Device: CliniMACS CD25 Reagent Device	Phase I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Infusion of Donor Lymphocytes Depleted of CD25+ Regulatory T-Cells in Patients With Relapsed Hematologic Malignancies After Matched Allogeneic Hematopoietic Stem Cell Transplantation

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To determine the feasibility of using the ClinMACS CD25 Reagent device to engineer a DLI product outlined in the protocol [ Time Frame: 3 years ] [ Designated as safety issue: No ]
To determine the safety of CD25+ Treg depleted DLI in this patient population. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess clinical response after infusions of CD25+ Treg depleted donor lymphocytes [ Time Frame: 3 years ] [ Designated as safety issue: No ]
To assess the immunologic impact of infusions of CD25+ Treg depleted donor lymphocytes [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	December 2007
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Used to engineer CD25+ depleted donor lymphocytes which will be infused intravenously over 15-30 minutes

Detailed Description:

The original marrow/stem cell 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 the amount of white blood cells collected will be measured. If the number of cells collected at the first leukopheresis is not enough, the donor will have a second leukopheresis procedure.
Once enough lymphocytes are collected from the donor, the CliniMACS CD25 Reagent System device will reduce the number of CD25+ Tregs. The CD25+ depleted donor lymphocytes will then be infused to the participant intravenously. Participants will be observed for about one hour after the infusion.
One, two, four and eight weeks after the DLI, participants will return to the clinic for follow-up visits. At each visit a physical exam, questions about the participants general health, and blood tests will be performed.

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 that have relapsed after HLA-A, -B, -C, and-DRBI matched allogeneic hematopoietic stem cell transplantation
At least 2 months following hematopoietic stem cell transplantation
Off any systemic immunosuppressive medication for treatment or prevention of GVHD, for a minimum of 2 weeks prior to study entry
Recipient with donor chimerism of 20% or greater within 6 weeks prior to DLI
Patient with less than 50% bone marrow involvement (% cellularity) and less than 5cm lymph nodes, in the 6 weeks prior to DLI
18 years of age or older
ECOG Performance Status score 0-2
Prior stem cell donor is medically fit to undergo leukapheresis procedure

Exclusion Criteria:

Relapsed CML in chronic phase
Prior donor lymphocyte infusion or other immunotherapy treatment within 8 weeks prior to enrollment
Chemotherapy within 4 weeks prior to enrollment
Clinically significant and active autoimmune disease in donor or patient. This is defined as autoimmune disease resulting in organ dysfunction and/or requiring systemic therapy
Evidence of active acute or chronic GVHD
Uncontrolled infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675831

Contacts

Contact: John Koreth, MBBS, DPhil	617-632-2949
Contact: Kimberly Phillips	617-632-6362	kphillips3@partners.org

Locations

United States, Massachusetts
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Miltenyi Biotec

Investigators

Principal Investigator:

John Koreth, MBBS, DPhil

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Dana-Farber Cancer Institute ( John Koreth, MBBS, DPhil )
Study ID Numbers:	07-193
Study First Received:	May 8, 2008
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00675831 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

CD25+
Tregs
DLI
Donor lymphocyte infusion

Study placed in the following topic categories:

Hematologic Neoplasms
Hematologic Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Hematologic Neoplasms
Hematologic Diseases

ClinicalTrials.gov processed this record on May 07, 2009