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

NCT04638790 | Recruiting Phase 3

• 1 other identifier: HL-Russia-1
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

EACODD-14

Outcome Measures

Primary Outcomes (5)

• Complete remission rate (CR)

  CR rate is defined as the proportion of patients achieving a CR after 3 months of chemotherapy (interim) and at the end of treatment

  up to 6 months

• Acute Toxicity

  The severity of the toxicities will be classified according to definitions of Common Terminology Criteria for Adverse Event (CTCAE) version 4.3. It will be determined by the incidence of severe, life- threatening (CTCAE grade 3, 4 and 5) and/or serious adverse events (Infusion-related reactions)

  6 months

• Late Toxicity

  The severity of the toxicities will be classified according to definitions of Common Terminology Criteria for Adverse Event (CTCAE) version 4.3. It will be determined by the incidence of severe, life- threatening (CTCAE grade 3, 4 and 5) and/or serious adverse events (Infusion-related reactions)

  5 years

• Event-Free Survival (EFS)

  EFS will be measured from the time from entry onto a study to any treatment failure including disease progression, or discontinuation of treatment for any reason (e.g., disease progression, toxicity, patient preference, initiation of new treatment lacking documented progression, or death)

  5 years

• Disease free survival (DFS)

  DFS will be measured from the time of occurrence of disease-free state or attainment of a CR to disease recurrence or death as a result of lymphoma or acute toxicity of treatment

  5 years

Secondary Outcomes (1)

• Overall survival (OS)

  5 years

Study Arms (3)

Early favorable HL

EXPERIMENTAL

HL without adverse prognostic factors

Drug: Doxorubicin; Drug: Bleomycin; Drug: Vinblastine; Drug: Dacarbazine

Early unfavorable HL

EXPERIMENTAL

Early unfavorable (stages IA-B, IIA bulky and/or extranodal lesions, age less than 50 years)

Drug: Doxorubicin; Drug: Vinblastine; Drug: Dacarbazine; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Dexamethasone

Advanced stages HL

EXPERIMENTAL

(age less than 50 years)

Drug: Etoposide; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Dexamethasone; Drug: Dacarbazine

Interventions

Doxorubicin DRUG

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

Also known as: ABVD

Early favorable HL; Early unfavorable HL

Bleomycin DRUG

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

Also known as: ABVD

Early favorable HL

Vinblastine DRUG

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

Also known as: ABVD

Early favorable HL; Early unfavorable HL

Dacarbazine DRUG

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

Also known as: ABVD

Early favorable HL; Early unfavorable HL

Etoposide DRUG

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

Also known as: EACODD-14

Advanced stages HL; Early unfavorable HL

Cyclophosphamide DRUG

650 mg/m2 i.v. day 1

Also known as: EACODD-14

Advanced stages HL; Early unfavorable HL

Vincristine DRUG

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

Also known as: EACODD-14

Advanced stages HL; Early unfavorable HL

Dexamethasone DRUG

20 mg i.v. days 1-3

Also known as: EACODD-14

Advanced stages HL; Early unfavorable HL

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Total bilirubin \<2 mg/dl without a pattern consistent with Gilbert's syndrome
• Creatinine within normal institutional limits or creatinine clearance \>50 mL/min/1.73 m2
• Females of childbearing must have a negative pregnancy test at medical supervision even if had been using effective contraception
• Life expectancy \> 6 months
• Able to adhere to the study visit schedule and other protocol requirements
• Sign (or their legally acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
• Access to PET-CT (positron emission computed tomography) scans facilities

You may not qualify if:

• 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.
• Abnormal QTc (corrected QT interval) interval prolonged (\>450 msec in males; \>470 msec in women)
• Uncontrolled infectious disease
• Human immunodeficiency virus (HIV) positivity or active infectious A, B or C hepatitis. HBsAg-negative patients with anti-HBc (hepatitis B core antigen) antibody and can be enrolled provided that Hepatitis B Virus (HBV)-DNA are negative and that antiviral treatment with nucleos(t)ide analogs is provided
• Uncompensated diabetes
• Refusal of adequate contraception
• Any medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment.

Sponsors & Collaborators

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

Study Sites (2)

Tata Memorial Hospital

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

RECRUITING

The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation

Moscow, 105203, Russia

RECRUITING

MeSH Terms

Conditions

Hodgkin Disease

Interventions

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

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Glycopeptides; Glycoconjugates; Peptides; Amino Acids, Peptides, and Proteins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Study Officials

• Vladislav Sarzhevskiy, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vladislav Sarzhevskiy, PhD

CONTACT

+7-910-436-00-40; vladsar100@gmail.com

Nikita Mochkin, PhD

CONTACT

+7-910-456-87-06; nickmed@yandex.ru

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 20, 2020
• Study Start: February 1, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1); RU (1)