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000119376 1001_ $$0P:(DE-He78)d8a0e60e5e095f3161ee0de3712409bc$$aSchlenk, Richard$$b0$$eFirst author
000119376 245__ $$aPomalidomide in myeloproliferative neoplasm-associated myelofibrosis.
000119376 260__ $$aBasingstoke$$bNature Publ. Group$$c2017
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000119376 520__ $$aMyeloproliferative neoplasm (MPN)-associated myelofibrosis is a MPN characterized by bone marrow fibrosis, cytopenias, splenomegaly and constitutional symptoms. Pomalidomide, an immune-modifying drug, is reported to improve anaemia and thrombocytopenia in some patients with MPN-associated myelofibrosis. We designed a phase 2 study of pomalidomide in patients with MPN-associated myelofibrosis and anaemia and/or thrombocytopenia and/or neutropenia. Subjects received pomalidomide 2.0 mg/day in cohort 1 (n=38) or 0.5 mg/day in cohort 2 (n=58). Prednisolone was added if there was no response after 3 months in cohort 1 and based on up-front randomization in cohort 2 if there was no response at 3 or 6 months. Response rates were 39% (95% confidence interval (CI), 26-55%) in cohort 1 and 24% (95% CI, 15-37%) in cohort 2. In a multivariable logistic regression model pomalidomide at 2.0 mg/day (odds ratio (OR), 2.62; 95% CI, 1.00-6.87; P=0.05) and mutated TET2 (OR, 5.07; 95% CI, 1.16-22.17; P=0.03) were significantly associated with responses. Median duration of responses was 13.0 months (range 0.9-52.7). There was no significant difference in response rates or duration in subjects receiving or not receiving prednisolone. Clinical trial MPNSG 01-09 is registered at ClinicalTrials.gov (NCT00949364) and clinicaltrialsregister.eu (EudraCT Number: 2009-010738-23)Leukemia advance online publication, 29 November 2016; doi:10.1038/leu.2016.299.
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000119376 7001_ $$aStegelmann, F.$$b1
000119376 7001_ $$aReiter, A.$$b2
000119376 7001_ $$aJost, E.$$b3
000119376 7001_ $$aGattermann, N.$$b4
000119376 7001_ $$aHebart, H.$$b5
000119376 7001_ $$aWaller, C.$$b6
000119376 7001_ $$aHochhaus, A.$$b7
000119376 7001_ $$aPlatzbecker, U.$$b8
000119376 7001_ $$aSchafhausen, P.$$b9
000119376 7001_ $$aBlau, I. W.$$b10
000119376 7001_ $$aVerbeek, W.$$b11
000119376 7001_ $$aHeidel, F. H.$$b12
000119376 7001_ $$aWerner, M.$$b13
000119376 7001_ $$aKreipe, H.$$b14
000119376 7001_ $$aTeleanu, V.$$b15
000119376 7001_ $$0P:(DE-He78)e15dfa1260625c69d6690a197392a994$$aBenner, A.$$b16$$udkfz
000119376 7001_ $$aDöhner, H.$$b17
000119376 7001_ $$aGrießhammer, M.$$b18
000119376 7001_ $$aDöhner, K.$$b19
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