RecruitingPhase 3NCT04638790

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

First Line Chemotherapy for Classical Hodgkin Lymphoma in Russia


Sponsor

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

Enrollment

300 participants

Start Date

Feb 1, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study (HL-Russia-1) is evaluating first-line chemotherapy regimens for classic Hodgkin lymphoma in Russia — a blood cancer that affects the lymphatic system. The study follows patients through treatment and tracks outcomes to determine which approach works best. **You may be eligible if...** - You are 18–65 years old (note: the protocol states 18–5 years which appears to be a typo for 65) - You have a confirmed new diagnosis of classical Hodgkin lymphoma that has not been treated - Your general health and blood count values are in an acceptable range - You have access to a PET-CT scan facility - Your life expectancy is greater than 6 months **You may NOT be eligible if...** - You have a different subtype of Hodgkin lymphoma (nodular lymphocyte predominant) - You have had prior chemotherapy or radiation - You are pregnant or breastfeeding - You have significant heart problems (irregular rhythm, reduced pumping function, or coronary disease) - You have uncontrolled infection or HIV Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDoxorubicin

25 mg/m2 i.v. day 1,15 for ABVD/AVD

DRUGBleomycin

10,000 units/m2 i.v. days 1,15 for ABVD

DRUGVinblastine

6 mg/m2 i.v. days 1,15 for ABVD/AVD

DRUGDacarbazine

375 mg/m2 i.v. days 1,15 for ABVD/AVD

DRUGEtoposide

100 mg/m2 i.v. days 1-3

DRUGDoxorubicin

50 mg/m2 i.v. day 1 for EACODD-14

DRUGCyclophosphamide

650 mg/m2 i.v. day 1

DRUGVincristine

1,4 mg/m2 i.v. day 8

DRUGDexamethasone

20 mg i.v. days 1-3

DRUGDacarbazine

375 mg/m2 i.v. day 1 for EACODD-14


Locations(2)

Tata Memorial Hospital

Mumbai, Opd-81 Main Building, Dr. E Borges Road, Parel 400012, India

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

View Full Details on ClinicalTrials.gov

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NCT04638790


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