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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Doxorubicin

    Drug

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

  • Bleomycin

    Drug

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

  • Vinblastine

    Drug

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

  • Dacarbazine

    Drug

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

  • Etoposide

    Drug

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

  • Doxorubicin

    Drug

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

  • Cyclophosphamide

    Drug

    650 mg/m2 i.v. day 1

  • Vincristine

    Drug

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

  • Dexamethasone

    Drug

    20 mg i.v. days 1-3

  • Dacarbazine

    Drug

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

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Early favorable HLExperimental treatment 4 interventions
Group B: Early unfavorable HLExperimental treatment 7 interventions
Group C: Advanced stages HLExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
up to 6 months
2

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)

Time frame
6 months
3

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)

Time frame
5 years
4

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)

Time frame
5 years

Secondary outcomes

1

Overall survival (OS)

OS is defined as the time from entry onto the clinical trial until death as a result of any cause

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
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