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

Recruiting Phase 3 Interventional Study
Hodgkin Lymphoma, Adult
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 50
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia · Other
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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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 * T…
Contacts

Vladislav Sarzhevskiy, PhD

+7-910-436-00-40

vladsar100@gmail.com

CONTACT

Nikita Mochkin, PhD

+7-910-456-87-06

nickmed@yandex.ru

CONTACT