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| ID | Type | Description | Link |
|---|---|---|---|
| Eudract Number 2004-000543-19 |
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The purpose of this trial was to evaluate efficacy and safety of adding Rituximab to dose-dense and High-Dose Chemotherapy (HDC) with Autologous Stem Cell Transplantation (ASCT) as first line treatment in young patients with DLBCL at Intermediate-High and High risk aaIPI score
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | 375 mg/m2 on day 1 |
| |
| Epirubicin |
| Measure | Description | Time Frame |
|---|---|---|
| Failure-free survival | Three years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Umberto Vitolo, MD | S.C. Ematologia II - OSP.S. GIOV.BATTISTA MOLINETTE - TORINO (TO) - | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Az. Ospedaliera SS. Antonio e Biagio e Cesare Arrigo | Alessandria | Italy | ||||
| Ospedale Regionale, Divisione di Oncologia, |
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| Drug |
110 mg/m2 on day 3 |
|
| Cyclophosphamide | Drug | 1200 mg/m2 on day 3 |
|
| Vincristine | Drug | 1.4 mg/m2 (maximum 2 mg) on day 3 |
|
| Prednisone | Drug | 40 mg/m2 from day 1 to 5 |
|
| Granulocyte-colony-stimulating factor | Drug | (G-CSF 5 μg/Kg/day) from day 5 to day 11 |
|
| Mitoxantrone | Drug | 8 mg/m2 for 3-day |
|
| Cytarabine ARA-C | Drug | 2 g/m2/12 hours for six doses in 3-hour infusion |
|
| Dexamethasone | Drug | 4 mg/m2/12 hours before ARA-C administration |
|
| Carmustine BCNU | Drug | 300 mg/m2 on day -7 |
|
| Etoposide | Drug | 100 mg/m2/12 hours |
|
| Melphalan | Drug | 140 mg/m2 on day -2 |
|
| Radiotherapy | Radiation | Involved Field Radiotherapy (IF-RT) |
|
| PBSC reinfusion | Procedure | ASCT |
|
| Aosta |
| Italy |
| Azienda Ospedaliera Ospedale Policlinico Consorziale | Bari | Italy |
| Osp. degli Infermi | Biella | Italy |
| Spedali Civili | Brescia | Italy |
| Centro Trapianti Midollo Osseo, P.O. Businco | Cagliari | Italy |
| Ospedale S. Gerardo | Monza | Italy |
| Osp. maggiore della Carità | Novara | Italy |
| Università degli Studi Policlinico Monteluce | Perugia | Italy |
| Divisione di Medicina, Ospedale Generale E. Agnelli, Pinerolo | Torino | Italy |
| Istituto per la Ricerca e la Cura del Cancro, Candiolo | Torino | Italy |
| Osp. S. Giovanni Battista "Molinette" | Torino | Italy |
| Ospedale di Chivasso e Ivrea | Torino | Italy |
| Stabilimento Ospedaliero Ciriè - | Torino | Italy |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D015251 | Epirubicin |
| D003520 | Cyclophosphamide |
| D014750 | Vincristine |
| D011241 | Prednisone |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D008942 | Mitoxantrone |
| D003907 | Dexamethasone |
| D002330 | Carmustine |
| D005047 | Etoposide |
| D008558 | Melphalan |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| 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 |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| 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 |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011809 | Quinones |
| D011246 | Pregnadienetriols |
| D013259 | Steroids, Fluorinated |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009603 | Nitroso Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D013812 | Therapeutics |
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