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Clinical Trial
. 2011 Sep;17(9):1343-51.
doi: 10.1016/j.bbmt.2011.02.002. Epub 2011 Feb 12.

Low risk of chronic graft-versus-host disease and relapse associated with T cell-depleted peripheral blood stem cell transplantation for acute myelogenous leukemia in first remission: results of the blood and marrow transplant clinical trials network protocol 0303

Steven M Devine  1 , Shelly Carter, Robert J Soiffer, Marcelo C Pasquini, Parameswaran N Hari, Anthony Stein, Hillard M Lazarus, Charles Linker, Edward A Stadtmauer, Edwin P Alyea 3rd, Carolyn A Keever-Taylor, Richard J O'Reilly
Affiliations
Clinical Trial

Low risk of chronic graft-versus-host disease and relapse associated with T cell-depleted peripheral blood stem cell transplantation for acute myelogenous leukemia in first remission: results of the blood and marrow transplant clinical trials network protocol 0303

Steven M Devine et al. Biol Blood Marrow Transplant. 2011 Sep.

Abstract

Graft-versus-host disease (GVHD) is most effectively prevented by ex vivo T cell depletion (TCD) of the allograft, but its role in the treatment of patients undergoing allogeneic hematopoietic cell transplantation (HCT) for acute myelogenous leukemia (AML) in complete remission (CR) remains unclear. We performed a phase 2 single-arm multicenter study to evaluate the role of TCD in AML patients in CR1 or CR2 up to age 65 years. The primary objective was to achieve a disease-free survival (DFS) rate of >75% at 6 months posttransplantation. A total of 44 patients with AML in CR1 (n = 37) or CR2 (n = 7) with a median age of 48.5 years (range, 21-59 years) received myeloablative chemotherapy and fractionated total body irradiation (1375 cGy) followed by immunomagnetically selected CD34-enriched, T cell‒depleted allografts from HLA-identical siblings. No pharmacologic GVHD prophylaxis was given. All patients engrafted. The incidence of acute GVHD grade II-IV was 22.7%, and the incidence of extensive chronic GVHD was 6.8% at 24 months. The relapse rate for patients in CR1 was 17.4% at 36 months. With a median follow-up of 34 months, DFS for all patients was 82% at 6 months, and DFS for patients in CR1 was 72.8% at 12 months and 58% at 36 months. HCT after myeloablative chemoradiotherapy can be performed in a multicenter setting using a uniform method of TCD, resulting in a low risk of extensive chronic GVHD and relapse for patients with AML in CR1.

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Conflict of interest statement

Conflict-of-interest/financial disclosure:

S.M.D., S.C., R.J.S., and R.J.O. have served as advisors to Miltenyi Biotec Inc

Figures

Figure 1
Figure 1
Recovery of lymphocytes by day post transplantation. Values are expressed as medians with standard errors. Shaded areas represent 25–75th percentile range for normal individuals. A) CD4+ cells; B) CD8+ cells; C) NK cells (CD56+ cells); D) B-cells
Figure 2
Figure 2
Cumulative incidence of A) Grades II–IV acute GVHD; B) Grades III–IV acute GVHD; C) Extensive/limited Chronic GVHD
Figure 3
Figure 3
Cumulative incidence of relapse for all transplanted patients
Figure 4
Figure 4
Kaplan-Meier estimates of A) Disease free survival for all transplanted patients; B) Disease free survival by remission state; C) Overall survival for all transplanted patients; D) Overall survival by remission state
See this image and copyright information in PMC

Comment in

References

    1. Copelan EA. Hematopoietic Stem-Cell Transplantation. N Engl J Med. 2006;354:1813–1826. - PubMed
    1. Cornelissen JJ, van Putten WLJ, Verdonck LF, et al. Results of a HOVON/SAKK donor versus no-donor analysis of myeloablative HLA-identical sibling stem cell transplantation in first remission acute myeloid leukemia in young and middle-aged adults: benefits for whom? Blood. 2007;109:3658–3666. - PubMed
    1. Koreth J, Schlenk R, Kopecky KJ, et al. Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia in First Complete Remission: Systematic Review and Meta-analysis of Prospective Clinical Trials. JAMA. 2009;301:2349–2361. - PMC - PubMed
    1. Slovak ML, Kopecky KJ, Cassileth PA, et al. Karyotypic analysis predicts outcome of preremission and postremission therapy in adult acute myeloid leukemia: a Southwest Oncology Group/Eastern Cooperative Oncology Group study. Blood. 2000;96:4075–4083. - PubMed
    1. Suciu S, Mandelli F, de Witte T, et al. Allogeneic compared with autologous stem cell transplantation in the treatment of patients younger than 46 years with acute myeloid leukemia (AML) in first complete remission (CR1): an intention-to-treat analysis of the EORTC/GIMEMAAML-10 trial. Blood. 2003;102:1232–1240. - PubMed

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