First Line Chemotherapy for Classical Hodgkin Lymphoma in Russia
The HL-Russia-1 is a non-randomized, open-label, multicenter, phase III, 3-arm study. The primary objective is to assess efficacy, safety and progression-free survival (PFS) of different approaches (earle favorable, early unfavorable and advanced stages) to first line chemotherapy for classical Hodgkin Lymphoma (HL).
• Histologically confirmed classical HL
• Previously untreated disease
• Age 18-5 years
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2
• Adequate organ and marrow function as defined below: absolute neutrophil count \>1,0 x109/L, platelets \>75 x109/L
• Total bilirubin \<2 mg/dl without a pattern consistent with Gilbert's syndrome
• Creatinine within normal institutional limits or creatinine clearance \>50 mL/min/1.73 m2
• Females of childbearing must have a negative pregnancy test at medical supervision even if had been using effective contraception
• Life expectancy \> 6 months
• Able to adhere to the study visit schedule and other protocol requirements
• Sign (or their legally acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
• Access to PET-CT (positron emission computed tomography) scans facilities