NCT04638790RecruitingPhase 3
First Line Chemotherapy for Classical Hodgkin Lymphoma in Russia (HL-Russia-1)
First Line Chemotherapy for Classical Hodgkin Lymphoma in Russia
Source: ClinicalTrials.gov · Last updated 27 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 16 Nov 2020
- Start date
- 1 Feb 2020
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
- Diseases
- Hodgkin lymphoma
- NCT number
- NCT04638790
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 300
- From 1 Feb 2020 to the primary completion date, 31 Dec 2026
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Uncontrolled infectious disease
- Uncompensated diabetes
- Any medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment.
Lab values
- 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)
Other
- Pregnant or lactating females
- Refusal of adequate contraception
Who the study is looking for
- 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
Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tata Memorial Hospital Coordinator of this site? Confirm its status | Mumbai | India | Recruiting |
| The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.