Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT01516567
Status:
UNKNOWN
Last Update Posted:
2021-03-18
First Post:
2012-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intergroup Trial for Children or Adolescents With Primary Mediastinal Large B-Cell Lymphoma: DA-EPOCH-Rituximab Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'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': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'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': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'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': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-17', 'studyFirstSubmitDate': '2012-01-19', 'studyFirstSubmitQcDate': '2012-01-24', 'lastUpdatePostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event free survival', 'timeFrame': '36 months', 'description': 'Minimum time to death from any cause, presence of viable cells in residue after 6th DA-EPOCH course, relapse, progressive disease, or second malignancy measured from registration.'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': '5 years', 'description': 'Overall survival'}, {'measure': 'Acute toxicity', 'timeFrame': '6 months', 'description': 'Acute toxicity during treatment according to NCI-CTC V4'}, {'measure': 'Long term toxicity', 'timeFrame': '5 years', 'description': 'Long term toxicity, especially immune reconstitution, cardiac toxicity'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Primary Mediastinal Large B Cell Lymphoma']}, 'referencesModule': {'references': [{'pmid': '34570655', 'type': 'DERIVED', 'citation': 'Burke GAA, Minard-Colin V, Auperin A, Alexander S, Pillon M, Delgado R, Zsiros J, Uyttebroeck A, Dartigues P, Miles RR, Kazanowska B, Chiang AK, Haouy S, Bollard CM, Csoka M, Wheatley K, Barkauskas DA, Adamson PC, Vassal G, Patte C, Gross TG. Dose-Adjusted Etoposide, Doxorubicin, and Cyclophosphamide With Vincristine and Prednisone Plus Rituximab Therapy in Children and Adolescents With Primary Mediastinal B-Cell Lymphoma: A Multicenter Phase II Trial. J Clin Oncol. 2021 Nov 20;39(33):3716-3724. doi: 10.1200/JCO.21.00920. Epub 2021 Sep 27.'}], 'seeAlsoLinks': [{'url': 'http://www.igr.fr', 'label': 'Institute Gustave Roussy web site'}]}, 'descriptionModule': {'briefSummary': 'Phase II trial to determine the efficacy of Dose Adjusted-EPOCH-Rituximab regimen in children and adolescent with primary mediastinal large B cell lymphoma in terms of event free survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven Primary Mediastinal Large B-Cell Lymphoma (PMLBL).\n* PMLBL without central nervous system (CNS) involvement.\n* 6 months to less than 18 years of age at the time of consent.\n* Males and females of reproductive potential must agree to use an effective contraceptive method during the treatment, and after the end of treatment: during twelve months for women, taking into account the characteristics of rituximab\n* Complete initial work-up within 8 days prior to treatment that allows definite staging.\n* Able to comply with scheduled follow-up and with management of toxicity.\n* Signed informed consent from patients and/or their parents or legal guardians\n\nExclusion Criteria:\n\n* Follicular lymphoma, mucosa-associated lymphoid tissue (MALT) and nodular marginal zone\n* PMLBL patients with CNS involvement\n* Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive HIV serology.\n* Evidence of pregnancy or lactation period.\n* There will be no exclusion criteria based on organ function.\n* Past or current anti-cancer treatment except corticosteroids during less than one week.\n* Tumor cell negative for CD20\n* Prior exposure to rituximab.\n* Severe active viral infection, especially hepatitis B.\n* Hepatitis B carrier status history of hepatitis B virus (HBV) or positive serology.\n* Participation in another investigational drug clinical trial.\n* Patients who, for any reason, are not able to comply with the national legislation.'}, 'identificationModule': {'nctId': 'NCT01516567', 'briefTitle': 'Intergroup Trial for Children or Adolescents With Primary Mediastinal Large B-Cell Lymphoma: DA-EPOCH-Rituximab Evaluation', 'nctIdAliases': ['NCT01595048'], 'organization': {'class': 'OTHER', 'fullName': 'Gustave Roussy, Cancer Campus, Grand Paris'}, 'officialTitle': 'Intergroup Trial for Children or Adolescents With B-Cell NHL or B-AL: Evaluation of Rituximab Efficacy and Safety in High Risk Patients - Phase II Trial of DA-EPOCH-Rituximab in PMLBL', 'orgStudyIdInfo': {'id': 'Inter B-NHL Ritux 2010 Phase 2'}, 'secondaryIdInfos': [{'id': '2010-019224-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DA-EPOCH-R', 'description': '6 courses of Dose Adjusted-EPOCH-Rituximab', 'interventionNames': ['Drug: Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab']}], 'interventions': [{'name': 'Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab', 'type': 'DRUG', 'description': '6 courses of Dose Adjusted-EPOCH-Rituximab Rituximab 375 mg/m² i.v.: one injection at each of the 6 courses of EPOCH.', 'armGroupLabels': ['DA-EPOCH-R']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Monrovia', 'country': 'Canada', 'facility': 'Children Oncology Group Operations centres'}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '1094', 'city': 'Budapest', 'country': 'Hungary', 'facility': '2nd Dept. of Pediatrics Semmelweis Univ.', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'Associazione Italiana di Ematologia ed Oncologia Pediatrica', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': "Emma Children's Hospital", 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Rectorat of Medical University', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Sociedad Española de Hematología y Oncología Pediátricas', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'University of Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}], 'overallOfficials': [{'name': 'Catherine PATTE, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institut Gustave Roussy, Villejuif, FRANCE'}, {'name': 'Thomas GROSS, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Children's Oncology Group, USA"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gustave Roussy, Cancer Campus, Grand Paris', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Oncology Group", 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}