Health Trials

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

ConditionHodgkin Lymphoma, Adult
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-50
SponsorState Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

About this trial

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

Qualifiers

Histologically confirmed classical HL

Previously untreated disease

Age 18-5 years

Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Doxorubicin
  • Bleomycin
  • Vinblastine
  • Dacarbazine
  • Etoposide
  • Doxorubicin
  • Cyclophosphamide
  • Vincristine
  • Dexamethasone
  • Dacarbazine

Treatment groups

300 Participants
are divided into 3 treatment groups

Locations

2
India
Tata Memorial Hospital MumbaiOpd-81 Main Building, Dr. E Borges Road, Parel 400012, India
Russia
The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation105203, Moscow Russia

Sponsors and collaborators

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

Lead sponsor

Source ClinicalTrials.gov