First Line Chemotherapy for Classical Hodgkin Lymphoma in Russia (HL-Russia-1)
NCT ID: NCT04638790
Last Updated: 2024-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2020-02-01
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Early favorable HL
HL without adverse prognostic factors
Doxorubicin
25 mg/m2 i.v. day 1,15 for ABVD/AVD
Bleomycin
10,000 units/m2 i.v. days 1,15 for ABVD
Vinblastine
6 mg/m2 i.v. days 1,15 for ABVD/AVD
Dacarbazine
375 mg/m2 i.v. days 1,15 for ABVD/AVD
Early unfavorable HL
Early unfavorable (stages IA-B, IIA bulky and/or extranodal lesions, age less than 50 years)
Doxorubicin
25 mg/m2 i.v. day 1,15 for ABVD/AVD
Vinblastine
6 mg/m2 i.v. days 1,15 for ABVD/AVD
Dacarbazine
375 mg/m2 i.v. days 1,15 for ABVD/AVD
Etoposide
100 mg/m2 i.v. days 1-3
Doxorubicin
50 mg/m2 i.v. day 1 for EACODD-14
Cyclophosphamide
650 mg/m2 i.v. day 1
Vincristine
1,4 mg/m2 i.v. day 8
Dexamethasone
20 mg i.v. days 1-3
Dacarbazine
375 mg/m2 i.v. day 1 for EACODD-14
Advanced stages HL
(age less than 50 years)
Etoposide
100 mg/m2 i.v. days 1-3
Doxorubicin
50 mg/m2 i.v. day 1 for EACODD-14
Cyclophosphamide
650 mg/m2 i.v. day 1
Vincristine
1,4 mg/m2 i.v. day 8
Dexamethasone
20 mg i.v. days 1-3
Dacarbazine
375 mg/m2 i.v. day 1 for EACODD-14
Interventions
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Doxorubicin
25 mg/m2 i.v. day 1,15 for ABVD/AVD
Bleomycin
10,000 units/m2 i.v. days 1,15 for ABVD
Vinblastine
6 mg/m2 i.v. days 1,15 for ABVD/AVD
Dacarbazine
375 mg/m2 i.v. days 1,15 for ABVD/AVD
Etoposide
100 mg/m2 i.v. days 1-3
Doxorubicin
50 mg/m2 i.v. day 1 for EACODD-14
Cyclophosphamide
650 mg/m2 i.v. day 1
Vincristine
1,4 mg/m2 i.v. day 8
Dexamethasone
20 mg i.v. days 1-3
Dacarbazine
375 mg/m2 i.v. day 1 for EACODD-14
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
50 Years
ALL
No
Sponsors
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State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
OTHER
Responsible Party
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Principal Investigators
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Vladislav Sarzhevskiy, PhD
Role: PRINCIPAL_INVESTIGATOR
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Locations
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Tata Memorial Hospital
Mumbai, Opd-81 Main Building, Dr. E Borges Road, Parel 400012, India
The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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Lingaraj Nayak, Dr.
Role: backup
Manju Sengar, Dr.
Role: backup
Bhausaheb Bagal, Dr.
Role: backup
Tanuja Shet, Dr.
Role: backup
Archi Agrawal, Dr.
Role: backup
Venkatesh Rangarajan, Dr.
Role: backup
Alok Shetty, Dr.
Role: backup
Hasmukh Jain, Dr.
Role: backup
Other Identifiers
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HL-Russia-1
Identifier Type: -
Identifier Source: org_study_id
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