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

Recruiting now · Phase 3

Conditions studied: Hodgkin Lymphoma, Adult

In brief

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).

Key facts

Study ID

NCT04638790

Run by

State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

People needed

300

Starts

2020-02-01

Expected to finish

2026-12-31

Last updated by the study team

2024-09-27

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Tata Memorial Hospital — Mumbai, Opd-81 Main Building, Dr. E Borges Road, Parel 400012, India (enrolling)
• The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation — Moscow, Russia (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.