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WT1 Peptide Vaccination in Acute Myeloid Leukemia (AML)

NCT ID: NCT00153582

Last Updated: 2006-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Brief Summary

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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

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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.

Conditions

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Acute Myeloid Leukemia Myelodysplastic Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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WT1 126-134 peptide

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Principal Investigators

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Ulrich Keilholz, MD

Role: PRINCIPAL_INVESTIGATOR

Charité

Locations

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Hematology&Oncology Charité CBF

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Carmen Scheibenbogen, MD

Role: CONTACT

Phone: +49-30-8445-4576

Email: [email protected]

Facility Contacts

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Ulrich Keilholz, MD

Role: primary

References

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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.

Reference Type RESULT
PMID: 14603333 (View on PubMed)

Other Identifiers

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Carreras 04/25f

Identifier Type: -

Identifier Source: secondary_id

HaemaCBFWT102

Identifier Type: -

Identifier Source: org_study_id