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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
History of Changes
  Purpose

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 Intervention Phase
Acute Myeloid Leukemia
Myelodysplastic Syndrome
 Biological: WT1 126-134 peptide
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Generation of T cell response

Secondary Outcome Measures:
  • Clinical outcome
  • Safety

Estimated Enrollment: 25
Study Start Date: April 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00153582

Contacts
Contact: Carmen Scheibenbogen, MD +49-30-8445-4576 carmen.scheibenbogen@charite.de

Locations
Germany
Hematology&Oncology Charité CBF Recruiting
Berlin, Germany, 12200
Contact: Ulrich Keilholz, MD     +49-30-8445-3906     ulrich.keilholz@charite.de    
Principal Investigator: Ulrich Keilholz, MD            
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Ulrich Keilholz, MD Charité
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00153582     History of Changes
Other Study ID Numbers: HaemaCBFWT102, Carreras 04/25f
Study First Received: September 8, 2005
Last Updated: February 21, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
 Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on June 17, 2013