WT1 Peptide Vaccination in Acute Myeloid Leukemia (AML)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2005 by Charite University, Berlin, Germany
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
First received: September 8, 2005
Last updated: February 21, 2006
Last verified: September 2005
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
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:

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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
Principal Investigator: Ulrich Keilholz, MD Charité
  More Information

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

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

ClinicalTrials.gov processed this record on January 23, 2017