Characteristics of CliniMACS® System CD34-Enriched T Cell-Depleted Grafts in a Multicenter Trial for Acute Myeloid Leukemia-Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Protocol 0303

被引：50

作者：

Keever-Taylor, Carolyn A. ^{[1
]}

Devine, Steven M. ^{[2
]}

Soiffer, Robert J. ^{[3
]}

Mendizabal, Adam ^{[4
]}

Carter, Shelly ^{[4
]}

Pasquini, Marcelo C. ^{[1
]}

Hari, Parameswaran N. ^{[1
]}

Stein, Anthony ^{[5
]}

Lazarus, Hillard M. ^{[6
]}

Linker, Charles ^{[7
]}

Goldstein, Steven C. ^{[8
]}

Stadtmauer, Edward A. ^{[8
]}

O'Reilly, Richard J. ^{[9
]}

机构：

[1] Med Coll Wisconsin, Milwaukee, WI 53226 USA

[2] Ohio State Univ, Columbus, OH 43210 USA

[3] Dana Farber Canc Inst, Boston, MA 02115 USA

[4] EMMES Corp, Rockville, MD USA

[5] City Hope Natl Med Ctr, Duarte, CA USA

[6] Univ Hosp Case Med Ctr, Cleveland, OH USA

[7] Univ Calif San Francisco, San Francisco, CA 94143 USA

[8] Univ Penn, Abramson Canc Ctr, Philadelphia, PA 19104 USA

[9] Mem Sloan Kettering Canc Ctr, New York, NY 10021 USA

来源：

BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION | 2012年 / 18卷 / 05期

关键词：

Allogeneic stem cell transplantation; T cell depletion; Clinical trial; Graft processing; Blood and Marrow Transplant Clinical Trials Network; VERSUS-HOST-DISEASE; ACUTE MYELOGENOUS LEUKEMIA; HIGH-RISK; PHASE-II; RELAPSE; DEVICE; REMISSION; SELECTION; CHILDREN;

D O I：

10.1016/j.bbmt.2011.08.017

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Eight centers participated in the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) protocol 0303 to determine the effect of extensive T cell depletion (TCD) on the outcome of HLA matched sibling donor transplantation for acute myeloid leukemia. One goal of the study was to determine if TCD could be performed uniformly among study sites. TCD was achieved using the CliniMACS (R) CD34 Reagent System for CD34 enrichment. Processed grafts needed to contain >= 2.0 x 10(6) CD34(+) cells/kg with a target of 5.0 x 10(6) CD34(+) cells/kg and <10(5) CD3(+) T cells/kg. Up to 3 collections were allowed to achieve the minimum CD34(+) cell dose. In total, 86 products were processed for 44 patients. Differences in the starting cell products between centers were seen in regard to total nucleated cells, CD34(+) cells, and CD3(+) T cells, which could in part be ascribed to a higher dose of granulocyte-colony stimulating factor used for mobilization early in the trial. Differences between centers in processing outcomes were minimal and could be ascribed to starting cell parameters or to differences in graft analysis methods. Multivariate analysis showed that CD34(+) cell recovery (66.1% +/- 20.3%) was inversely associated with the starting number of CD34(+) cells (P = .02). Median purity of the CD34 enriched fraction was 96.7% (61.5%-99.8%) with monocytes and B cells the most common impurity. All patients received the minimum CD34(+) cell dose, and 39 patients (89%) came within 10% or exceeded the target CD34(+) cell dose without exceeding the maximum T cell dose. All patients proceeded to transplantation and all achieved initial engraftment. Products processed at multiple centers using the CliniMACS System for CD34 enrichment were comparably and uniformly highly enriched for CD34(+) cells, with good CD34(+) cell recovery and very low CD3(+) T cell content. Biol Blood Marrow Transplant 18: 690-697 (2012) (C) 2012 American Society for Blood and Marrow Transplantation

引用

页码：690 / 697

页数：8

共 18 条

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