Actively Recruiting
First Line Chemotherapy for Classical Hodgkin Lymphoma in Russia (HL-Russia-1)
Led by State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia · Updated on 2024-09-27
300
Participants Needed
2
Research Sites
360 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
First Line Chemotherapy for Classical Hodgkin Lymphoma in Russia (HL-Russia-1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed classical Hodgkin Lymphoma
- Previously untreated disease
- Age between 18 and 50 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Adequate organ and marrow function including neutrophil count >1.0 x10^9/L and platelets >75 x10^9/L
- Total bilirubin less than 2 mg/dl without Gilbert's syndrome pattern
- Normal creatinine or creatinine clearance >50 mL/min/1.73 m2
- Negative pregnancy test for women of childbearing potential
- Life expectancy greater than 6 months
- Ability to follow study visit schedule and protocol requirements
- Signed informed consent
- Access to PET-CT scan facilities
You will not qualify if you...
- Nodular Lymphocyte Predominant Hodgkin Lymphoma
- Prior chemotherapy or radiation therapy
- Pregnant or lactating females
- Cardiac arrhythmia, conduction abnormalities, ischemic heart disease, left ventricular hypertrophy, or left ventricular ejection fraction ≤50%
- Prolonged corrected QT interval (>450 msec in males; >470 msec in females)
- Uncontrolled infection
- HIV positivity or active hepatitis A, B, or C
- Hepatitis B core antibody positive without antiviral treatment and detectable HBV-DNA
- Uncontrolled diabetes
- Refusal to use adequate contraception
- Any medical or psychiatric illness that may interfere with treatment completion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Tata Memorial Hospital
Mumbai, Opd-81 Main Building, Dr. E Borges Road, Parel 400012, India
Actively Recruiting
2
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, 105203
Actively Recruiting
Research Team
V
Vladislav Sarzhevskiy, PhD
CONTACT
N
Nikita Mochkin, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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