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

Last updated: September 25, 2024
Sponsor: State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Overall Status: Active - Recruiting

Phase

3

Condition

Lymphoma

Treatment

Vincristine

Dexamethasone

Cyclophosphamide

Clinical Study ID

NCT04638790
HL-Russia-1
  • Ages 18-50
  • All Genders

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).

Eligibility Criteria

Inclusion

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 >1,0x109/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 >50mL/min/1.73 m2

  • Females of childbearing must have a negative pregnancy test at medical supervisioneven 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 consentdocument indicating that they understand the purpose of and procedures required forthe study and are willing to participate in the study.

  • Access to PET-CT (positron emission computed tomography) scans facilities

Exclusion

Exclusion Criteria:

  • Nodular Lymphocyte Predominant HL

  • Prior chemotherapy or radiation therapy

  • Pregnant or lactating females

  • Cardiac arrhythmia, conduction abnormalities, ischemic cardiopathy, left ventricularhypertrophy or left ventricular ejection fraction (LVEF) ≤50% at echocardiography.

  • Abnormal QTc (corrected QT interval) interval prolonged (>450 msec in males; >470msec in women)

  • Uncontrolled infectious disease

  • Human immunodeficiency virus (HIV) positivity or active infectious A, B or Chepatitis. HBsAg-negative patients with anti-HBc (hepatitis B core antigen) antibodyand can be enrolled provided that Hepatitis B Virus (HBV)-DNA are negative and thatantiviral 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.

Study Design

Total Participants: 300
Treatment Group(s): 8
Primary Treatment: Vincristine
Phase: 3
Study Start date:
February 01, 2020
Estimated Completion Date:
December 31, 2026

Study Description

The study is devoted to patients affected with Hodgkin Lymphoma in Russia.

The study aims to assess the efficacy and safety of three different approaches to first line chemotherapy for classical Hodgkin Lymphoma (HL):

  1. Early favourable (stages I-IIA without unfavorable risk factors). Patients will receive two courses of standard ABVD (Adriamycin, bleomycin, vinblastine, and dacarbazine). Those with a PET-2 (positron emission tomography) negative scan (Deauville Score 1-3) will proceed with radiotherapy on initially involved site (20 Gy). Those with a PET-2 Deauville score 4 will proceed with additional 2 ABVD courses. After that, those with a PET-4 negative scan (Deauville Score 1-3) will proceed with radiotherapy on initially involved site (30 Gy). In case of PET-4 positive scan after 4 ABVD cycles (Deauville score 4-5) patients will be planned to perform the biopsy and in case of positive results, proceed to high-dose chemotherapy with autologous stem cell transplantation (HDT with ASCT). In case of negative results of the biopsy, they will proceed with additional 2 ABVD courses and restage again. Those with a PET-6 negative scan (Deauville Score 1-3) will proceed with radiotherapy on initially involved site (30 Gy). In case of PET-6 positive scan (Deauville score 4-5) patients will be proceeded to HDT with ASCT.

    Those with a PET-2 Deauville score 5 after 2 ABVD courses will be planned to perform the biopsy and in case of positive results, proceed to HDT with ASCT. In case of negative results of the biopsy they will proceed with additional 2 ABVD courses and restage again. Those with a PET-4 negative scan (Deauville Score 1-3) will proceed with radiotherapy on initially involved site (30 Gy). In case of PET-4 positive scan (Deauville score 4-5) patients will be proceeded to HDT with ASCT.

  2. Early unfavorable (stages IA-B, IIA bulky and/or extranodal lesions, patients younger 50 years). Patients will receive two courses of EACODD-14 (etoposide 100 mg/m2 days 1-3, doxorubicin 50 mg/m2 day 1, cyclophosphamide 650 mg/m2 day 1, vincristine 1,4 mg/m2 day 8, dacarbazine 375 mg/m2 day 1, dexamethasone 20 mg days 1-3; cycle is repeated every 14 days). Those with a PET-2 negative scan (Deauville Score 1-3) will be deescalated to 2 courses of AVD (Adriamycin, vinblastine, and dacarbazine) and consolidative radiotherapy on initially involved site (30 Gy). Those with a PET-2-positive scan (Deauville score 4-5) will proceed with additional 2 EACODD-14 courses. After that, those with a PET-4 negative scan (Deauville Score 1-3) will proceed with radiotherapy on initially involved site (30 Gy). In case of PET-4 positive scan after 4 EACODD-14 cycles (Deauville score 4-5) patients will proceed with additional 2 EACODD-14 courses. After that, those with a PET-6 negative scan (Deauville Score 1-3) will proceed with radiotherapy on initially involved site (30 Gy). In case of PET-6 positive scan (Deauville score 4-5) patients will be proceeded to HDT with ASCT.

  3. Advanced stages (younger 50 years). Patients will receive two courses of EACODD-14. Those with a PET-2 negative scan (Deauville Score 1-3) will proceed with 4 additional courses of EACODD-14. After that, patients with residual tumor ˂ 4 cm, will stop the therapy and start the follow-up phase. Patients with residual tumor ≥ 4 cm, will undergo consolidative radiotherapy on residual tumor (30 Gy). Those with a PET-2-positive scan (Deauville score 4-5) will proceed with additional 4 additional courses of EACODD-14. After that, those with a PET-6 negative scan (Deauville Score 1-3) will proceed with radiotherapy on residual tumor ≥ 2,5 cm (30 Gy). In case of PET-6 positive scan (Deauville score 4-5) patients will be proceeded to HDT with ASCT.

Connect with a study center

  • Tata Memorial Hospital

    Mumbai, OPD-81 Main building, Dr. E Borges Road, Parel 400012
    India

    Active - 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
    Russian Federation

    Active - Recruiting

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