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 Blood, 25 June 2009, Vol. 113, No. 26, pp. 6541-6548.
Prepublished online as a Blood First Edition Paper on April 23, 2009; DOI 10.1182/blood-2009-02-202598.

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CLINICAL TRIALS AND OBSERVATIONS

A clinical and immunologic phase 2 trial of Wilms tumor gene product 1 (WT1) peptide vaccination in patients with AML and MDS

Ulrich Keilholz1,*, Anne Letsch1,*, Antonia Busse1, Anne Marie Asemissen1, Sandra Bauer2, Igor Wolfgang Blau1, Wolf-Karsten Hofmann1, Lutz Uharek1, Eckhard Thiel1, and Carmen Scheibenbogen2

1 Department of Hematology and Oncology, Charité Campus Benjamin Franklin (CBF), Berlin; and 2 Department of Medical Immunology, Charité Campus Charité Mitte (CCM), Berlin, Germany

This study investigated the immunogenicity of Wilms tumor gene product 1 (WT1)–peptide vaccination in WT1-expressing acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) patients without curative treatment option. Vaccination consisted of granulocyte-macrophage colony-stimulating factor subcutaneously days 1 to 4, and WT1.126-134 peptide and 1 mg keyhole limpet hemocyanin on day 3. The initial 9 patients received 4 vaccinations biweekly, then monthly, and the subsequent 10 patients received continual biweekly vaccination. Seventeen AML patients and 2 refractory anemia with excess blasts patients received a median of 11 vaccinations. Treatment was well tolerated. Objective responses in AML patients were 10 stable diseases (SDs) including 4 SDs with more than 50% blast reduction and 2 with hematologic improvement. An additional 4 patients had clinical benefit after initial progression, including 1 complete remission and 3 SDs. WT1 mRNA levels decreased at least 3-fold from baseline in 35% of patients. In 8 of 18 patients, WT1-tetramer+ T cells increased in blood and in 8 of 17 patients in bone marrow, with a median frequency in bone marrow of 0.18% at baseline and 0.41% in week 18. This WT1 vaccination study provides immunologic, molecular, and preliminary evidence of potential clinical efficacy in AML patients, warranting further investigations.


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