Active Immunotherapy of Patients With Acute Myeloid Leukemia Using Autologous Dendritic Cells Transfected With RNA Encoding Leukemia-associated Antigens
Patients ≥ 18 years of either gender with AML of non-favorable risk profile in CR or CRi not
being eligible for allogeneic stem cell transplantation will receive as intradermal
injections at two different sites up to ten immunotherapies with autologous DCs presenting
two leukemia-associated antigens and one CMV antigen conserved in cryomedium over a time
span of 26 weeks. Phase I will test the safety and toxicity in a small group of patients
(n=6). After at least four vaccinations of three patients, the safety and toxicity data will
be presented to the Data safety monitoring board (DSMB). Only after the DSMB has no
objectives against the continuation of the trial, further patients will be included into the
trial. Again, after three more patients, receiving a minimum of four vaccines, clinical data
will be presented to the DSMB, and phase I will be terminated. The decision for continuation
of the trial will be done by the DSMB. If there are no objectives by the DSMB, the trial
will continue and evaluation will be started in a larger group of patients (n=14). During
the phase II trial, safety and toxicity will be evaluated in a larger co-hort of patients).
Besides, preliminary assessment of efficacy will be performed including induction of
immunological responses to leukemia associated antigens as well as to a viral antigen (CMV),
MRD control, time to progression of disease and ECOG performance status.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
% of grade I/II and grade III/IV toxicities
30 weeks
Yes
Marion Subklewe, PD Dr
Principal Investigator
Department of Medicine III; Hospital of the University of Munich,
Germany: Paul-Ehrlich-Institut
2010-022446-24
NCT01734304
December 2012
April 2018
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