| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019224-31 | EudraCT Number |
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| Name | Class |
|---|---|
| Children's Oncology Group | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DA-EPOCH-R | Experimental | 6 courses of Dose Adjusted-EPOCH-Rituximab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab | Drug | 6 courses of Dose Adjusted-EPOCH-Rituximab Rituximab 375 mg/m² i.v.: one injection at each of the 6 courses of EPOCH. |
| Measure | Description | Time Frame |
|---|---|---|
| Event free survival | 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. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Overall survival | 5 years |
| Acute toxicity | Acute toxicity during treatment according to NCI-CTC V4 | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine PATTE, MD | Institut Gustave Roussy, Villejuif, FRANCE | Study Chair |
| Thomas GROSS, MD | Children's Oncology Group, USA | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Leuven | 3000 | Belgium | |||
| Children Oncology Group Operations centres |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34570655 | Derived | 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. |
| Label | URL |
|---|---|
| Institute Gustave Roussy web site | View source |
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| Long term toxicity | Long term toxicity, especially immune reconstitution, cardiac toxicity | 5 years |
| Monrovia |
| Canada |
| Gustave Roussy | Villejuif | 94805 | France |
| 2nd Dept. of Pediatrics Semmelweis Univ. | Budapest | 1094 | Hungary |
| Associazione Italiana di Ematologia ed Oncologia Pediatrica | Padova | 35128 | Italy |
| Emma Children's Hospital | Amsterdam | 1105 AZ | Netherlands |
| Rectorat of Medical University | Wroclaw | Poland |
| Sociedad Española de Hematología y Oncología Pediátricas | Valencia | 46010 | Spain |
| University of Birmingham | Birmingham | United Kingdom |
| ID | Term |
|---|---|
| D005047 | Etoposide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D003520 | Cyclophosphamide |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D000617 | Aminoglycosides |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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