WT1 Peptide Vaccination in Acute Myeloid Leukemia (AML)

This study is currently recruiting participants.

Verified by Charite University, Berlin, Germany, September 2005

First Received: September 8, 2005 Last Updated: February 21, 2006 History of Changes

Sponsored by:	Charite University, Berlin, Germany
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00153582

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 II

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Wilms' Tumor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of WT1 126-134 Peptide Vaccination in Combination With Adjuvants GM-CSF and KLH in AML

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:

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.

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

Study placed in the following topic categories:

Leukemia
Acute Myelocytic Leukemia
Preleukemia
Precancerous Conditions
Hematologic Diseases
Wilms' Tumor

Myelodysplastic Syndromes
Adjuvants, Immunologic
Wilms Tumor
Leukemia, Myeloid
Bone Marrow Diseases
Leukemia, Myeloid, Acute

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Disease
Precancerous Conditions
Hematologic Diseases
Myelodysplastic Syndromes
Leukemia, Myeloid
Leukemia, Myeloid, Acute

Leukemia
Preleukemia
Neoplasms
Pathologic Processes
Syndrome
Bone Marrow Diseases

ClinicalTrials.gov processed this record on May 07, 2009