Efficacy of WT1-peptide vaccination for remission maintenance in patients with acute myeloid leukemia: A controlled phase II trial - WT1-peptide study

• Conditions: acute myeloid leukemiaPatients with acute myeloid leukemia in 1st or 2nd CR or leukemia-free state are eligible for this study. Patients in 1st CR must have unfavorable prognostic factors. Definition of high-risk patients in 1st CR include: Unfavourable cytogenetics (abnormalities of 3, 5, 7 or complex karyotype); normal karyotype and no CR after 1st induction therapy or no or incomplete consolidation chemotherapy.; MedDRA version: 8.1Level: LLTClassification code 10000887Term: Acute myeloid leukemia in remission

• Registration Number: EUCTR2005-005242-39-DE
• Lead Sponsor: Charité Campus Benjamin Franklin, Med. Clinic III,Dept. of Hematology,Oncology, Transfusion Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

Male or female > 18 years of age
Diagnosis of AML
First CR or leukemia-free state in presence of unfavorable prognostic factors or second CR or leukemia-free state ( for definition see page 16).
WT1 expression in leukemia blast cells
Adequate bone marrow function: leucocytes > 1.0 x 109/L, neutrophils > 0.5 x 109/L, platelets > 50 x 109/L, hemoglobin > 9.0 g/dL
ECOG performance status 0-2
Absence of significant liver toxicity from chemotherapy: SGOT, SGPT, AP, g-GT < 3 x ULN
Adequate renal function: serum creatinine < 1.5 mg/d
If of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post-dosing.
Signed written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Other serious illness or medical conditions:
Unstable cardiac disease despite treatment, congestive heart failure > NYHA grade 2-Significant renal disease
Active neurologic or psychiatric disorders including dementia or seizures;-Active uncontrolled infection
Active disseminated intravascular coagulation
Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
Known allergic/hypersensitivity reaction to any of the components of the treatment·
Legal incapacity or limited legal capacity
Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to assess the rate of remissions in the group of HLA-A2 carrying AML patients receiving vaccination at the time point when a 50% relapse rate has been documented in the non-HLA-A2 control group.;Secondary Objective: Time to progression<br>Overall survival<br>Correlation of T cell response with remission-free survival<br>Safety profile;Primary end point(s): The rate of relapses in the active treatment arm at the time 50% of relapses have been recorded in the control arm (event-triggered analysis).