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

Summary

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).

Eligibility

Inclusion Criteria:

* 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

Exclusion Criteria:

* Nodular Lymphocyte Predominant HL
* Prior chemotherapy or radiation therapy
* Pregnant or lactating females
* 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)
* Uncontrolled infectious disease
* 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
* Uncompensated diabetes
* Refusal of adequate contraception
* Any medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment.

Conditions2

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