First Line Chemotherapy for Classical Hodgkin Lymphoma in Russia (HL-Russia-1)

Korábbi kezelés

• Prior chemotherapy or radiation therapy
• Human immunodeficiency virus (HIV) positivity or active infectious A, B or C hepatitis. HBsAg-negative patients with anti-HBc (hepatitis B core antigen) antibody and can be enrolled provided that Hepatitis B Virus (HBV)-DNA are negative and that antiviral treatment with nucleos(t)ide analogs is provided

Más betegség

• Uncontrolled infectious disease
• Uncompensated diabetes
• Any medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment.

Laborértékek

• Nodular Lymphocyte Predominant HL
• Cardiac arrhythmia, conduction abnormalities, ischemic cardiopathy, left ventricular hypertrophy or left ventricular ejection fraction (LVEF) ≤50% at echocardiography.
• Abnormal QTc (corrected QT interval) interval prolonged (>450 msec in males; >470 msec in women)

Egyéb

• Pregnant or lactating females
• Refusal of adequate contraception

• 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