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

NCT04638790 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-09-27

No results posted yet for this study

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).

Conditions

  • Hodgkin Lymphoma, Adult

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

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Vladislav Sarzhevskiy, PhD · State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • India
  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04638790 on ClinicalTrials.gov