Status:
COMPLETED
Infusion of Donor Lymphocytes Depleted of CD25+ Regulatory T-cells in Patients With Relapsed Hematologic Malignancies
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Miltenyi Biomedicine GmbH
Conditions:
Hematologic Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 wit...
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 laborato...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00675831
Start Date
December 1 2007
End Date
January 1 2013
Last Update
September 29 2016
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115