acute myeloid leukemia Patients 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)
Conditions
Interventions
Product Name: WT1 126-134
Product Code: WT1 126-134
Pharmaceutical Form: Powder for injection*
Sponsors
Charité Campus Benjamin Franklin, Med. Clinic III,Dept. of Hematology,Oncology, Transfusion Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Overall survival Correlation of T cell response with remission-free survival 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). | — |
Countries
Germany
Outcome results
None listed