Titolo della ricerca: Phase 1 trials in patients with hematologic malignancies
Progetto di ricerca: Phase 1 clinical trials investigate and collect clinical data on the interaction between a new drug/drug combination in the treated patients. The primary objective of a phase 1 clinical trial is to evaluate the safety and tolerability of the new drug/drug combination in the enrolled patients, adjusting dosing schemes to define side effects and the best tolerated dose. Safety will be assessed by quantifying the toxicities and grades experienced by the treated patients, including serious adverts (SAEs) and events of clinical interest (ECIs). A secondary endpoint is to record the anti-tumor activity. A further secondary objective could be to evaluate the modulation of different biologic parameters of the host and/or to characterize the pharmacokinetic (PK) profile. The purpose of the present project is to record all data of the treated patients appropriate electronic case report forms (eCRFs), and to allow an always more refined execution of the progressively increasing phase 1 clinical studies carried out at the “Hematology Trial Unit” of the Center of Hematology, Policlinico Umberto 1, “Sapienza” University of Rome.