6 תוצאות
Phase 1 The Phase 1 portion of the study will enroll patients into a 3+3 dose-escalation design to assess the dose-limiting toxicities (DLTs) and establish an Maximum tolerated dose (MTD)/Recommended Phase 2 does (RP2D). Up to 9 sequential AVM0703 dose cohorts are planned. In each cohort, 3 to 6
ARM A: DECITABINE (DAC)
Decitabine (DAC) will be administered at 20 mg/m2 intravenously daily for 5 days every 28 days.
Treatment will be delayed at the discretion of the investigator (up to D56) for febrile neutropenia (≥ 38.5°C; absolute neutrophil count [ANC], < 1,000/μL), clinical and/or
[Changes to the protocol made until the stage of the statistical analysis plan, before data analysis and also before unblinding.]
1. Objective
1.1 Main Objective
We aim to determine, through mean INR difference between formulations, whether there is therapeutic equivalency between the branded
5.2 AUTOLOGOUS PBSCS HARVESTING
5.2.1. PBSCs will be collected during recovery phase after the second cycle of HDAC consolidation chemotherapy.
5.2.2. For mobilization, recombinant human granulocyte- colony-stimulating factor (G-CSF, Filgrastim) will be given subcutaneously at a dose of 10 mcg/kg
Acute pancreatitis represents the most common complication after ERCP. The reported incidence of this complication varies from less than 1% to 40%, but rates of about 10% are reported in most prospective studies involving non-selected patients. Although most episodes (about 90%) of post-ERCP