Cellular immunotherapy for acute myeloid leukemia using dendritic cells pulsed with WT1 peptide and zoledronate

UMIN ID: UMIN000000796

Registered date:10/08/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: acute myeloid leukemia
• Date of first enrollment: 2007/07/01
• Target sample size: 6
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Administer monocyte-derived dendritic cells intradermally and intravenously every 2 weeks for 5 doses

Outcome(s)

• Primary Outcome: Toxicity of NCI-CTC grade 1-4
• Secondary Outcome: 1. Immune responses to WT1 and KLH 2. Responses of gamma delta T cells 3. Complete remission rate 4. Partial remission rate evaluated by microscopy 5. Partial remission rate evaluated by flow cytometry or WT1 mRNA real-time RT-PCR

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: 69years-old
• Gender: Male and Female
• Exclude criteria: 1. There is deep seated active infection 2. There are other malignancies 3. There are leukemic lesions in the central nervous system 4. There is active autoimmune disease 5. Positive for HBs Ag, HCV Ab, HTLV-I Ab, HIV Ab, or serological test for syphilis 6. Responsible doctors judged the patient inappropriate for the trial

Related Information

• Primary Sponsor: Department of Hematology and Oncology, Kyoto University Hospital
• Source(s) of Monetary Support: Medinet Co., Ltd.