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WT1 Peptide Vaccination in Acute Myeloid Leukemia (AML)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00153582
First received: September 8, 2005
Last updated: February 21, 2006
Last verified: September 2005

September 8, 2005
February 21, 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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
Biological: WT1 126-134 peptide
Not Provided
Mailander 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. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
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
Both
18 Years and older
No
Contact: Carmen Scheibenbogen, MD +49-30-8445-4576 carmen.scheibenbogen@charite.de
Germany
 
NCT00153582
HaemaCBFWT102, Carreras 04/25f
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