Expired Study
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Durham, North Carolina 27710


Purpose:

The central hypothesis of this study is that use of a less toxic chemotherapy preparative regimen for allogeneic hematopoietic stem cell transplantation in combination with T cell depletion with alemtuzumab for patients with high risk hematologic malignancies will allow effective control of disease and improved disease free and overall survival compared with historical expectations. Specifically, the objectives are to estimate toxicity, disease free, progression free, event free, and overall survival rates in patients treated with alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation; evaluate immune recovery following this reduced intensity allogeneic immunotherapy; develop an in vitro assay to allow patient individualized targeted dosing.


Study summary:

The central hypothesis of this study is that use of a less toxic chemotherapy preparative regimen for allogeneic hematopoietic stem cell transplantation in combination with T cell depletion with alemtuzumab for patients with high risk hematologic malignancies will allow effective control of disease and improved disease free and overall survival compared with historical expectations. Specifically, the objectives are to estimate toxicity, disease free, progression free, event free and overall survival rates in patients treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation; evaluate immune recovery following this reduced intensity allogeneic immunotherapy; develop an in vitro assay to allow patient individualized targeted dosing. The study population is HIV negative, adult patients who are not pregnant but have confirmed diagnosis of disease; must have CALGB PS 0, 1, or 2; must have a 3-6/6 HLA-matched related donor or 8/8 (A, B, C, DRB1, DQ are the primary determinants) or better HLA-matched unrelated donor who is evaluated and deemed able to provide PBPCs and/or marrow by the transplant team. The target population of patients is those with a high chance of progressive lymphoid or myelomatous diseases, progressive myeloid diseases, marrow failure syndromes or myeloproliferative disorders.


Criteria:

Inclusion Criteria: - Patients must have their diagnosis confirmed at the transplant center. - Performance status must be CALGB PS 0, 1, or 2. - Patients must have a 3-6/6 HLA-matched related donor or 8/8 or better allele level match MUD matched unrelated donor (at A,B, C, DRB1, DQ). - HIV negative. - Women of child bearing potential must have a negative pregnancy serum beta-HCG test within 1 week of starting therapy. - Patients > or equal to 18 years of age are eligible. - Patients must have a MUGA and/or ECHO or cardiac MR and PFTs with DLCO performed before transplant. - Specific patient populations: - Group A) Patients with a high chance of progressive lymphoid or myelomatous diseases. - Group B) Patients with a high chance of progressive myeloid diseases, marrow failure syndromes or myeloproliferative disorders Exclusion Criteria: - Pregnant or lactating women. - Patients with other major medical or psychiatric illnesses which the treating physician feels could seriously compromise tolerance to this protocol. - Patients with uncontrolled, progressive infections. - Patients who are good candidates for long term disease control with standard chemotherapy or radiation or high dose therapy and autologous support. - Patients with active CNS disease.


NCT ID:

NCT00597714


Primary Contact:

Principal Investigator
David Rizzieri, MD
Duke University Health System


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27710
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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