NCT04638790 First Line Chemotherapy for Classical Hodgkin Lymphoma in Russia (HL-Russia-1)
| NCT ID | NCT04638790 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia |
| Condition | Hodgkin Lymphoma, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2020-02-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 300 participants in total. It began in 2020-02-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Vladislav Sarzhevskiy, PhD
PRINCIPAL INVESTIGATOR
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Frequently Asked Questions
Who can join the NCT04638790 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Hodgkin Lymphoma, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04638790 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 300 participants.
Is NCT04638790 currently recruiting?
Yes, NCT04638790 is actively recruiting participants. Contact the research team at vladsar100@gmail.com for enrollment information.
Where is the NCT04638790 trial being conducted?
This trial is being conducted at Mumbai, India, Moscow, Russia.
Who is sponsoring the NCT04638790 clinical trial?
NCT04638790 is sponsored by State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia. The principal investigator is Vladislav Sarzhevskiy, PhD at State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia. The trial plans to enroll 300 participants.