Back to resultsWT1 Peptide Vaccination in Acute Myeloid Leukemia (AML)
Primary Purpose
Acute Myeloid Leukemia, Myelodysplastic Syndrome
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
WT1 126-134 peptide
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia
Eligibility 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
Sites / Locations
- Hematology&Oncology Charité CBFRecruiting
Outcomes
Primary Outcome Measures
Generation of T cell response
Secondary Outcome Measures
Clinical outcome
Safety
Full Information
NCT ID
NCT00153582
First Posted
September 8, 2005
Last Updated
February 21, 2006
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT00153582
Brief Title
WT1 Peptide Vaccination in Acute Myeloid Leukemia (AML)
Official Title
Phase II Study of WT1 126-134 Peptide Vaccination in Combination With Adjuvants GM-CSF and KLH in AML
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Myelodysplastic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
WT1 126-134 peptide
Primary Outcome Measure Information:
Title
Generation of T cell response
Secondary Outcome Measure Information:
Title
Clinical outcome
Title
Safety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carmen Scheibenbogen, MD
Phone
+49-30-8445-4576
Email
carmen.scheibenbogen@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Keilholz, MD
Organizational Affiliation
Charité
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hematology&Oncology Charité CBF
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrich Keilholz, MD
Phone
+49-30-8445-3906
Email
ulrich.keilholz@charite.de
First Name & Middle Initial & Last Name & Degree
Ulrich Keilholz, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
14603333
Citation
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. doi: 10.1038/sj.leu.2403186. No abstract available.
Results Reference
result
Learn more about this trial
WT1 Peptide Vaccination in Acute Myeloid Leukemia (AML)
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