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WT1 Peptide Vaccination in Acute Myeloid Leukemia (AML)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Myelodysplastic Syndrome Biological: WT1 126-134 peptide Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of WT1 126-134 Peptide Vaccination in Combination With Adjuvants GM-CSF and KLH in AML
Study Start Date : April 2002

Primary Outcome Measures :
  1. Generation of T cell response

Secondary Outcome Measures :
  1. Clinical outcome
  2. Safety

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00153582

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Contact: Carmen Scheibenbogen, MD +49-30-8445-4576

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Hematology&Oncology Charité CBF Recruiting
Berlin, Germany, 12200
Contact: Ulrich Keilholz, MD    +49-30-8445-3906   
Principal Investigator: Ulrich Keilholz, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
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Principal Investigator: Ulrich Keilholz, MD Charité

Publications of Results:
Layout table for additonal information Identifier: NCT00153582     History of Changes
Other Study ID Numbers: HaemaCBFWT102
Carreras 04/25f
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: February 22, 2006
Last Verified: September 2005
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Immunologic Factors
Physiological Effects of Drugs