The aim of this study is to determine the feasibility and safety of an autologous DC
immunotherapy in patients with AML of non-favorable risk profile.
Biological: DC vaccination for postremission therapy in AML
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Full eligibility criteria for NCT01734304
Ages eligible for Study
18 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
Patients male or female, age ≥ 18 years, biological age ≤ 75 years
Patients with AML of non-favorable risk profile or with AML and sole NPM1 mutation and confirmed increase of MRD load as detected by RQ-PCR (in two measurements at least four weeks apart)
CR or CRi after intensive induction chemotherapy (TAD, HAM, sHAM, 3+7 anthracycline + cytarabine regimen, or equivalent)
Negative HIV test, negative hepatitis B and C test
Negative pregnancy test in women of childbearing potential
Ability to understand and willingness to sign a written informed consent
Patients suitable for allogeneic HSCT (indication for allogeneic HSCT, adequate donor, no contraindication for allogeneic HSCT)
Patients with AML with favorable risk profile:
APL (AML M3)
inv(16), t(16;16), or del(16) as sole anomaly
t(8;21) as sole anomaly
biallelic CEBPA mutation as sole anomaly
NPM1 mutation as sole anomaly, unless with confirmed increase of MRD load
Prior allogeneic HSCT
Anemia (Hb < 9,0 mg/dl)
Leukopenia (< 4,0 G/l)
Transfusion refractory thrombocytopenia (< 30 G/l platelets despite adequate number of transfusions)
Active clinically relevant autoimmune disease
Active immunodeficiency syndromes
Known allergy to GM-CSF, TNF, IFN-γ, IL-4, IL-1 beta, PGE2, R848, Human AB Serum, DMSO, HSA
Continuous therapy with corticosteroids or other immunosuppressive drugs during the trial
Present substance abuse or any other factor that could limit the subject's ability to comply with study procedures
Severe organ dysfunction:
Creatinine > 2,5 mg/ml
Bilirubin > 3,0 mg/ml
ALAT and ASAT > 3 x upper normal limit
Respiratory insufficiency with pO2 < 60 mmHg
Clinically relevant coronary heart disease of ventricular arrhythmia, congestive heart failure > grade II NYHA
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
Simultaneous participation in another clinical trial or participation in any clinical trial involving an investigational medicinal product within 30 days prior to written informed consent for this trial Exclusion criteria regarding special restrictions for females:
Current or planned pregnancy or nursing women
Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration and at least 3 months thereafter (such as oral, injectable, or im-plantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized/hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases
All locations for NCT01734304
Hospital of the University of Munich, LMU; Department od Medicine III
Munich, Germany, 81377
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Tris trial is registered with FDA with number: NCT01734304. The sponsor of the trial is Ludwig-Maximilians - University of Munich and it is looking for 20 volunteers for the current phase.
Official trial title: Active Immunotherapy of Patients With Acute Myeloid Leukemia Using Autologous Dendritic Cells Transfected With RNA Encoding Leukemia-associated Antigens
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