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WT1 Peptide Vaccination in Acute Myeloid Leukemia (AML)

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ClinicalTrials.gov Identifier: NCT00153582
Recruitment Status : Unknown
Verified September 2005 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : February 22, 2006
Information provided by:
Charite University, Berlin, Germany

September 8, 2005
September 12, 2005
February 22, 2006
April 2002
Not Provided
Generation of T cell response
Same as current
Complete list of historical versions of study NCT00153582 on ClinicalTrials.gov Archive Site
  • Clinical outcome
  • Safety
Same as current
Not Provided
Not Provided
WT1 Peptide Vaccination in Acute Myeloid Leukemia (AML)
Phase II Study of WT1 126-134 Peptide Vaccination in Combination With Adjuvants GM-CSF and KLH in AML
In this trial, HLA-A2+ patients with active AML are vaccinated with a peptide from the leukemia-associated antigen WT1 together with immunological adjuvants keyhole limpet hemocyanin (KLH) as T-helper protein and granulocyte macrophage colony stimulating factor (GM-CSF) 4 times bi-weekly, then monthly.
In this phase II trial HLA-A2+ patients with active AML without curative treatment option are vaccinated with WT1 126-134 peptide mixed with adjuvant KLH as T-helper protein and GM-CSF 4 times bi-weekly, then monthly.
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
Biological: WT1 126-134 peptide
Not Provided
Mailänder V, Scheibenbogen C, Thiel E, Letsch A, Blau IW, Keilholz U. Complete remission in a patient with recurrent acute myeloid leukemia induced by vaccination with WT1 peptide in the absence of hematological or renal toxicity. Leukemia. 2004 Jan;18(1):165-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
Not Provided
Not Provided

Inclusion Criteria:

  • AML or myelodysplastic syndromes (MDS)
  • Partial response (PR) or complete response (CR) or smoldering course without option for allogeneic stem cell transplantation
  • HLA-A2+
  • WT1-expression in bone marrow
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Carreras 04/25f
Not Provided
Not Provided
Not Provided
Not Provided
Charite University, Berlin, Germany
Not Provided
Principal Investigator: Ulrich Keilholz, MD Charité
Charite University, Berlin, Germany
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP