Unmanipulated Haploidentical Reduced-Intensity Stem Cell Transplantation Using Fludarabine, Busulfan, Low-Dose Antithymocyte Globulin, and Steroids for Patients in Non-Complete Remission or at High Risk of Relapse : A Prospective Multicenter Phase I/II Study in Japan
Copyright © 2015 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved..
This prospective, multicenter phase I/II study of unmanipulated HLA-haploidentical reduced-intensity stem cell transplantation using a low dose of anti-T lymphocyte globulin (ATG) and steroid was conducted in 5 institutions in Japan. Thirty-four patients with hematologic malignancies who were in an advanced stage or at a high risk of relapse at the time of transplantation were enrolled. Among them, 7 patients underwent transplantation as a second transplantation because of relapse after the previous allogeneic stem cell transplantation. The conditioning regimen consisted of fludarabine, busulfan, and ATG (Fresenius, 8 mg/kg), and graft-versus-host disease (GVHD) prophylaxis consisted of tacrolimus and methylprednisolone (1 mg/kg). All patients except 1 (97.1%) achieved donor-type engraftment. Rapid hematopoietic engraftment was achieved, with neutrophils > .5 × 10(9)/L on day 11 and platelets > 20 × 10(9)/L on day 17.5. Treatment was started for ≥grade I GVHD, and the cumulative incidences of acute grade I and grade II to IV GVHD were 27.5% and 30.7%, respectively. The incidence of chronic GVHD (extensive type) was 20%. Fourteen patients (41.2%) had a relapse. The cumulative incidence of transplantation-related mortality at 1 year after transplantation was 26.5%. The survival rate at day 100 was 88.2%. The survival rates at 1 year for patients with complete remission (CR)/chronic phase (n = 8) and non-CR (n = 26) status before transplantation were 62.5% and 42.3%, respectively. In the multivariate analysis, non-CR status before transplantation was the only factor significant prognostic factor of increased relapse (P = .0424), which tended to be associated with a lower survival rate (P = .0524). This transplantation protocol is safe and feasible, if a suitable donor is not available in a timely manner. As the main cause of death was relapse and not GVHD, more intensified conditioning or attenuation of GVHD prophylaxis and/or donor lymphocyte infusion may be desirable for patients with non-CR status.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2015 |
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| Erschienen: |
2015 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:21 |
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| Enthalten in: |
Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation - 21(2015), 8 vom: 09. Aug., Seite 1495-505 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Ikegame, Kazuhiro [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 06.04.2016 Date Revised 17.07.2015 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.bbmt.2015.04.012 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
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| 245 | 1 | 0 | |a Unmanipulated Haploidentical Reduced-Intensity Stem Cell Transplantation Using Fludarabine, Busulfan, Low-Dose Antithymocyte Globulin, and Steroids for Patients in Non-Complete Remission or at High Risk of Relapse |b A Prospective Multicenter Phase I/II Study in Japan |
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| 500 | |a Date Completed 06.04.2016 | ||
| 500 | |a Date Revised 17.07.2015 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2015 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a This prospective, multicenter phase I/II study of unmanipulated HLA-haploidentical reduced-intensity stem cell transplantation using a low dose of anti-T lymphocyte globulin (ATG) and steroid was conducted in 5 institutions in Japan. Thirty-four patients with hematologic malignancies who were in an advanced stage or at a high risk of relapse at the time of transplantation were enrolled. Among them, 7 patients underwent transplantation as a second transplantation because of relapse after the previous allogeneic stem cell transplantation. The conditioning regimen consisted of fludarabine, busulfan, and ATG (Fresenius, 8 mg/kg), and graft-versus-host disease (GVHD) prophylaxis consisted of tacrolimus and methylprednisolone (1 mg/kg). All patients except 1 (97.1%) achieved donor-type engraftment. Rapid hematopoietic engraftment was achieved, with neutrophils > .5 × 10(9)/L on day 11 and platelets > 20 × 10(9)/L on day 17.5. Treatment was started for ≥grade I GVHD, and the cumulative incidences of acute grade I and grade II to IV GVHD were 27.5% and 30.7%, respectively. The incidence of chronic GVHD (extensive type) was 20%. Fourteen patients (41.2%) had a relapse. The cumulative incidence of transplantation-related mortality at 1 year after transplantation was 26.5%. The survival rate at day 100 was 88.2%. The survival rates at 1 year for patients with complete remission (CR)/chronic phase (n = 8) and non-CR (n = 26) status before transplantation were 62.5% and 42.3%, respectively. In the multivariate analysis, non-CR status before transplantation was the only factor significant prognostic factor of increased relapse (P = .0424), which tended to be associated with a lower survival rate (P = .0524). This transplantation protocol is safe and feasible, if a suitable donor is not available in a timely manner. As the main cause of death was relapse and not GVHD, more intensified conditioning or attenuation of GVHD prophylaxis and/or donor lymphocyte infusion may be desirable for patients with non-CR status | ||
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| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Anti–T lymphocyte globulin | |
| 650 | 4 | |a Haploidentical stem cell transplantation | |
| 650 | 4 | |a Reduced-intensity conditioning | |
| 650 | 4 | |a Steroid | |
| 650 | 7 | |a Antilymphocyte Serum |2 NLM | |
| 650 | 7 | |a Steroids |2 NLM | |
| 650 | 7 | |a Vidarabine |2 NLM | |
| 650 | 7 | |a FA2DM6879K |2 NLM | |
| 650 | 7 | |a Busulfan |2 NLM | |
| 650 | 7 | |a G1LN9045DK |2 NLM | |
| 650 | 7 | |a fludarabine |2 NLM | |
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| 700 | 1 | |a Yoshida, Takashi |e verfasserin |4 aut | |
| 700 | 1 | |a Yoshihara, Satoshi |e verfasserin |4 aut | |
| 700 | 1 | |a Daimon, Takashi |e verfasserin |4 aut | |
| 700 | 1 | |a Shimizu, Hiroaki |e verfasserin |4 aut | |
| 700 | 1 | |a Maeda, Yoshinobu |e verfasserin |4 aut | |
| 700 | 1 | |a Ueda, Yasunori |e verfasserin |4 aut | |
| 700 | 1 | |a Kaida, Katsuji |e verfasserin |4 aut | |
| 700 | 1 | |a Ishii, Shinichi |e verfasserin |4 aut | |
| 700 | 1 | |a Taniguchi, Kyoko |e verfasserin |4 aut | |
| 700 | 1 | |a Okada, Masaya |e verfasserin |4 aut | |
| 700 | 1 | |a Tamaki, Hiroya |e verfasserin |4 aut | |
| 700 | 1 | |a Okumura, Hirokazu |e verfasserin |4 aut | |
| 700 | 1 | |a Kaya, Hiroyasu |e verfasserin |4 aut | |
| 700 | 1 | |a Kurokawa, Toshiro |e verfasserin |4 aut | |
| 700 | 1 | |a Kodera, Yoshihisa |e verfasserin |4 aut | |
| 700 | 1 | |a Taniguchi, Shuichi |e verfasserin |4 aut | |
| 700 | 1 | |a Kanda, Yoshinobu |e verfasserin |4 aut | |
| 700 | 1 | |a Ogawa, Hiroyasu |e verfasserin |4 aut | |
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