Status:
TERMINATED
Donor T Cells in Treating Patients With High-Risk Hematologic Cancer Undergoing Donor Peripheral Blood Stem Cell Transplant
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Graft Versus Host Disease
Leukemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
RATIONALE: A donor peripheral stem cell transplant helps stop the growth of cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow ...
Detailed Description
OBJECTIVES: Primary * To determine the maximum tolerated dose (MTD) of CD4+/CD25+ cells that can be safely administered to patients undergoing HLA-identical sibling donor Peripheral Blood Progenitor...
Eligibility Criteria
Inclusion
- Diagnosis of a high-risk hematologic malignancy, including any of the following:
- Acute lymphocytic leukemia
- Acute myelocytic leukemia
- Chronic myelogenous leukemia
- Myelodysplastic syndrome
- Non-Hodgkin lymphoma
- Multiple myeloma
- Meet eligibility criteria and co-enrolled in one of the following University of Minnesota protocols:
- MT2001-02 consisting of myeloablative prep (cyclophosphamide and total body irradiation) followed by HLA-identical sibling peripheral blood progenitor cells (PBPC) transplantation
- MT2001-10 consisting of nonmyeloablative prep (cyclophosphamide, fludarabine and total body irradiation) followed by HLA-identical sibling PBPC transplantation
- Voluntarily written informed consent
- Must have an HLA-identical sibling donor available, meeting the following criteria:
- 12 to 75 years of age, \>40 kg body weight and in good health
- Matched to recipient for HLA-A, B,DRB1 identical sibling match to recipient
- Must be able and willing to have a separate apheresis collection performed on day -21 for the purposes of this study (in addition to the apheresis required for the transplant protocol)
- Human immunodeficiency virus nucleic acid testing (HIV-NAT) negative, Human T-lymphotropic virus 1 (HTLV-1), HTLV-2 negative, hepatitic B and C negative
Exclusion
- Not pregnant or nursing
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00725062
Start Date
June 1 2008
End Date
April 1 2010
Last Update
November 29 2017
Active Locations (1)
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1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455