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RECRUITING
NCT04638790
PHASE3

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

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

View on ClinicalTrials.gov

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).

Official title: First Line Chemotherapy for Classical Hodgkin Lymphoma in Russia

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2020-02-01

Completion Date

2026-12-31

Last Updated

2024-09-27

Healthy Volunteers

No

Interventions

DRUG

Doxorubicin

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

DRUG

Bleomycin

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

DRUG

Vinblastine

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

DRUG

Dacarbazine

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

DRUG

Etoposide

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

DRUG

Doxorubicin

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

DRUG

Cyclophosphamide

650 mg/m2 i.v. day 1

DRUG

Vincristine

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

DRUG

Dexamethasone

20 mg i.v. days 1-3

DRUG

Dacarbazine

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