Compares first chemotherapy approaches for Hodgkin lymphoma in adults
Tests chemotherapy combinations as first treatment in adults with Hodgkin lymphoma.
Plain-language title generated from the registry record
Registry title: First Line Chemotherapy for Classical Hodgkin Lymphoma in Russia (HL-Russia-1)
Key facts
- Where
- Mumbai, IndiaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 50 years old?
Source: NCT04638790, who can take part
Where in India
- Tata Memorial HospitalMumbai, IndiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
- Trial code
- NCT04638790
- Record updated
- 27 September 2024
- Original description
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).Read full original descriptionShow less
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).
Inclusion: 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: 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; Uncontrolled infectious disease; Uncompensated diabetes; Any medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment; 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); Pregnant or lactating females; Refusal of adequate contraception.