Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-05 @ 3:02 PM
Study NCT ID:
NCT07171827
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2025-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-CD30 (Brentuximab Vedotin) With AVD Versus ABVD Chemotherapy Protocol Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079963', 'term': 'Brentuximab Vedotin'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D014747', 'term': 'Vinblastine'}, {'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D001761', 'term': 'Bleomycin'}], 'ancestors': [{'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-06', 'studyFirstSubmitDate': '2025-09-06', 'studyFirstSubmitQcDate': '2025-09-06', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '2 years post-procedure', 'description': 'Progression-free Survival was recorded.'}], 'secondaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': '30 days after the end of treatment', 'description': 'Overall Response Rate (ORR) is the percentage of participants who achieved complete remission (CR) or partial remission (PR) at the end of treatment with randomized regimen.'}, {'measure': 'Overall survival', 'timeFrame': '2 years post-procedure', 'description': 'Overall survival was recorded.'}, {'measure': 'Incidence of adverse events', 'timeFrame': '30 days after the end of frontline therapy', 'description': 'Incidence of adverse events such as toxicity, incidence, severity and type starting after administration of the first dose till 30 days after end of frontline therapy were recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anti-CD30', 'Brentuximab', 'Doxorubicin', 'Vinblastine', 'Dacarbazine', 'Frontline', 'Advanced Classical Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': 'This study will be held in the clinical oncology department, Helwan University, and Police Hospital, aiming to compare the efficacy and safety of anti-CD30 (BV) + Doxorubicin, Vinblastine, and Dacarbazine (AVD) versus the standard of care Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) as frontline therapy in patients with advanced classical Hodgkin lymphoma.', 'detailedDescription': 'Hodgkin lymphoma (HL) is a malignancy that typically originates from germinal center B-lymphocytes. It is subdivided into classical type, which represents 95% of histopathology of HL cases (with four histological subtypes, namely, nodular sclerosis, mixed-cellularity, lymphocyte-rich, and lymphocyte-depleted), and nodular lymphocyte-predominant HL.\n\nFor patients with newly diagnosed Ann Arbor stage III/IV (advanced stage) HL, 70% are expected to be cured after treatment with Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (ABVD), which has been the preferred standard of care in the United States for many years.\n\nThe Risk-adapted therapy for advanced-stage Hodgkin lymphoma (RATHL) study assessed de-escalation to Doxorubicin, Vinblastine, and Dacarbazine (AVD) in patients with stage IIB, III, or IV HL (Deauville 1-3) and found that positron emission tomography (PET)-adapted de-escalation to AVD failed to demonstrate noninferiority compared with ABVD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18- 70 Years.\n* Histopathology: confirmed classical Hodgkin Lymphoma according to the current World Health Organization (WHO) classification. CD30 positive by immunohistochemistry.\n* Stage III or IV Hodgkin lymphoma (HL) by the Ann Arbor classification system.\n* Treatment-naïve.\n* Laboratory:\n\n * complete blood count: absolute neutrophil counts (≥1500 per cubic millimeter), platelet counts (≥75,000 per cubic millimeter), and hemoglobin levels (≥8 g per deciliter) (except for patients with involvement of the marrow).\n * liver function test: total bilirubin level \\<1.5 times the upper limit of normal and alanine aminotransferase or aspartate aminotransferase levels \\<3 times the upper limit of normal.\n * kidney function test: serum creatinine level, \\<2.0 mg per deciliter or creatinine clearance or calculated creatinine clearance, \\>40 ml per minute.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n\nExclusion Criteria:\n\n* Histopathology: Nodular lymphocyte predominant Hodgkin lymphoma and non-Hodgkin lymphoma.\n* Cerebral/meningeal disease.\n* Prior treatment with chemotherapy, radiotherapy, or any immunotherapy within 12 weeks of first study drug dose.\n* Known human immunodeficiency virus (HIV) positive, known hepatitis B surface antigen-positive, or known active hepatitis C infection.\n* Known organ failure.\n* Cardiac: left ventricular ejection fraction \\< 50%, myocardial infarction within 2 years of randomization or current uncontrolled cardiovascular conditions, including arrhythmias, congestive heart failure, angina, evidence of acute ischemia, or active conduction system abnormalities.\n* Female patients who are breastfeeding or having a positive serum pregnancy test during the randomization period or on day 1 before starting treatment.\n* Neurotoxicity, including symptomatic neurologic disease, comprising normal daily activities, any sensory or motor peripheral neuropathy.\n* Pulmonary diffusion capacity \\>25 % lower than predicted value as retrieved by pulmonary function test for each patient before randomization.\n* Known hypersensitivity to recombinant proteins, murine proteins, or any component of the included drugs formulation.'}, 'identificationModule': {'nctId': 'NCT07171827', 'briefTitle': 'Anti-CD30 (Brentuximab Vedotin) With AVD Versus ABVD Chemotherapy Protocol Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Helwan University'}, 'officialTitle': 'A Prospective Study Comparing Anti CD30 (Brentuximab Vedotin) With AVD Versus ABVD Chemotherapy Protocol Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma', 'orgStudyIdInfo': {'id': '40-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BV+AVD group', 'description': 'Patients received Brentuximab Vedotin (BV)+ Doxorubicin, Vinblastine, and Dacarbazine (AVD) drug regimen by intravenous infusion on Days 1 and 15 of each 28-day cycle.', 'interventionNames': ['Drug: Brentuximab Vedotin + Doxorubicin, Vinblastine, and Dacarbazine']}, {'type': 'EXPERIMENTAL', 'label': 'ABVD group', 'description': 'Patients received Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) drug regimen by intravenous infusion on Days 1 and 15 of each 28-day cycle.', 'interventionNames': ['Drug: Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine']}], 'interventions': [{'name': 'Brentuximab Vedotin + Doxorubicin, Vinblastine, and Dacarbazine', 'type': 'DRUG', 'description': 'Patients received Brentuximab Vedotin (BV)+ Doxorubicin, Vinblastine, and Dacarbazine (AVD) drug regimen by intravenous infusion on Days 1 and 15 of each 28-day cycle.', 'armGroupLabels': ['BV+AVD group']}, {'name': 'Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine', 'type': 'DRUG', 'description': 'Patients received Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) drug regimen by intravenous infusion on Days 1 and 15 of each 28-day cycle.', 'armGroupLabels': ['ABVD group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11795', 'city': 'Helwan', 'country': 'Egypt', 'facility': 'Helwan University', 'geoPoint': {'lat': 29.84144, 'lon': 31.30084}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helwan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Clinical Oncology, Faculty of Medicine, Helwan University, Egypt.', 'investigatorFullName': 'Marwa Nazih Abdel Gawad', 'investigatorAffiliation': 'Helwan University'}}}}