Universität zu Köln

Kornblit, Brian, Maloney, David G., Storer, Barry E., Maris, Michael B., Vindelov, Lars, Hari, Parameswaran ORCID: 0000-0002-8800-297X, Langston, Amelia A., Pulsipher, Michael A., Bethge, Wolfgang A., Chauncey, Thomas R., Lange, Thoralf, Petersen, Finn B., Huebel, Kai, Woolfrey, Ann E., Flowers, Mary E. D., Storb, Rainer and Sandmaier, Brenda M. (2014). A randomized phase II trial of tacrolimus, mycophenolate mofetil and sirolimus after non-myeloablative unrelated donor transplantation. Haematologica, 99 (10). S. 1624 - 1632. PAVIA: FERRATA STORTI FOUNDATION. ISSN 0390-6078

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Abstract

The study is a randomized phase II trial investigating graft-versus-host disease prophylaxis after non-myeloablative (90 mg/m(2) fludarabine and 2 Gy total body irradiation) human leukocyte antigen matched unrelated donor transplantation. Patients were randomized as follows: arm 1 - tacrolimus 180 days and mycophenolate mofetil 95 days (n=69); arm 2 - tacrolimus 150 days and mycophenolate mofetil 180 days (n=71); arm 3 - tacrolimus 150 days, mycophenolate mofetil 180 days and sirolimus 80 days (n=68). All patients had sustained engraftment. Grade II-IV acute graft-versus-host disease rates in the 3 arms were 64%, 48% and 47% at Day 150, respectively (arm 3 vs. arm 1 (hazard ratio 0.62; P=0.04). Owing to the decreased incidence of acute graft-versus-host disease, systemic steroid use was lower at Day 150 in arm 3 (32% vs. 55% in arm 1 and 49% in arm 2; overall P=0.009 by hazard ratio analysis). The Day 150 incidence of cytomegalovirus reactivation was lower in arm 3 (arm 1, 54%; arm 2, 47%; arm 3, 22%; overall P=0.002 by hazard ratio analysis). Non-relapse mortality was comparable in the three arms at two years (arm 1, 26%; arm 2, 23%; arm 3, 18%). Toxicity rates and other outcome measures were similar between the three arms. The addition of sirolimus to tacrolimus and mycophenolate mofetil is safe and associated with lower incidence of acute graft-versus-host disease and cytomegalovirus reactivation.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Kornblit, Brian UNSPECIFIED UNSPECIFIED UNSPECIFIED Maloney, David G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Storer, Barry E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Maris, Michael B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Vindelov, Lars UNSPECIFIED UNSPECIFIED UNSPECIFIED Hari, Parameswaran UNSPECIFIED orcid.org/0000-0002-8800-297X UNSPECIFIED Langston, Amelia A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Pulsipher, Michael A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bethge, Wolfgang A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Chauncey, Thomas R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lange, Thoralf UNSPECIFIED UNSPECIFIED UNSPECIFIED Petersen, Finn B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Huebel, Kai UNSPECIFIED UNSPECIFIED UNSPECIFIED Woolfrey, Ann E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Flowers, Mary E. D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Storb, Rainer UNSPECIFIED UNSPECIFIED UNSPECIFIED Sandmaier, Brenda M. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-428034
DOI:	10.3324/haematol.2014.108340
Journal or Publication Title:	Haematologica
Volume:	99
Number:	10
Page Range:	S. 1624 - 1632
Date:	2014
Publisher:	FERRATA STORTI FOUNDATION
Place of Publication:	PAVIA
ISSN:	0390-6078
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language VERSUS-HOST-DISEASE; STEM-CELL TRANSPLANTATION; BONE-MARROW-TRANSPLANTATION; TOTAL-BODY IRRADIATION; LOW-DOSE METHOTREXATE; GVHD PROPHYLAXIS; COMPARING METHOTREXATE; CYCLOSPORINE; COMBINATION; RISK Multiple languages Hematology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/42803