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The study has the purpose to compare R-CHOP versus R-mini-CEOP in elderly patients (>65 years) with Diffuse Large B Cell Lymphoma (DLBCL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-CHOP | Experimental | R-CHOP (every 21 days) for six courses Cyclophosphamide: 750 mg/m2, IV, day 1 Doxorubicin: 50 mg/m2, IV, day 1 Vincristine: 1.4 (max 2) mg/m2, IV, day 1 Prednisone: 75 mg/m2, IV, days 1-5 Rituximab: 375 mg/m2, IV, day 1 G-CSF: 300 µg tota, SC; days 7-11 |
|
| R-mini-CEOP | Experimental | R-miniCEOP (every 21 days)for six courses Cyclophosphamide: 50 mg/m2, IV, day 1 Epirubicin: 50 mg/m2, IV, day 1 Vinblastine: 5 mg/m2, IV, day 1 Prednisone: 60 mg/m2, IV/PO, days 1-5 Rituximab: 375 mg/m2, IV, day 1 G-CSF: 300 µg tota, SC; days 7-11 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | 750 mg/mq IV, day 1 |
| |
| Cyclophosphamide |
| Measure | Description | Time Frame |
|---|---|---|
| Event Free Survival (EFS) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission (CR) rate | 2 years | |
| Disease Free Survival (DFS) | 2 years | |
| Multidimensional Evaluation Scale for the definition of "frail" and "non frail" patients |
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Inclusion Criteria:
Patients with untreated DLBCL aged 66 to 80 years without major accompanying diseases and considered as "non frail".
Patients were classified as "non frail" (fit) if they had
Patients HIV negativity;
Concurrent malignancy;
Written Informed Consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francesco Merli, MD | U.O.A. di Ematologia Azienda Ospedale S. Maria Nuova | Study Chair |
| Marilena Bertini, MD | U.O.A. di Ematologia Ospedale Molinette | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S.C. di Ematologia, Spedali Civili | Brescia | Brescia | 25123 | Italy | ||
| Ospedale di Vigevano |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29975624 | Derived | Shi Q, Schmitz N, Ou FS, Dixon JG, Cunningham D, Pfreundschuh M, Seymour JF, Jaeger U, Habermann TM, Haioun C, Tilly H, Ghesquieres H, Merli F, Ziepert M, Herbrecht R, Flament J, Fu T, Coiffier B, Flowers CR. Progression-Free Survival as a Surrogate End Point for Overall Survival in First-Line Diffuse Large B-Cell Lymphoma: An Individual Patient-Level Analysis of Multiple Randomized Trials (SEAL). J Clin Oncol. 2018 Sep 1;36(25):2593-2602. doi: 10.1200/JCO.2018.77.9124. Epub 2018 Jul 5. | |
| 21895543 |
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| Drug |
50 mg/mq IV, day 1 |
|
| Doxorubicin | Drug | 50 mg/mq IV, day1 |
|
| Vincristine | Drug | 1,4 mg/mq (max 2 mg)IV, day 1 |
|
| Prednisone | Drug | 75 mg/mq IV, days 1-5 |
|
| Prednisone | Drug | 60 mg/mq IV/PO, days 1-5 |
|
| Epirubicin | Drug | 50 mg/mq IV, day 1 |
|
| Vinblastine | Drug | 5 mg/mq IV, day 1 |
|
| Rituximab | Drug | 375 mg/mq IV, day 1 |
|
| G-CSF | Drug | 300 µg tot., SC; days 7-11 |
|
| 2 years |
| Vigevano |
| Pavia |
| Italy |
| Ospedale Garibaldi-Nesima | Catania | Italy |
| Ospedale civile Divisione di Ematologia | Civitanova Marche (MC) | Italy |
| Ospedale San Sebastiano | Correggio (RE) | Italy |
| Presidio Ospedaliero Annunziata | Cosenza | Italy |
| Istituto Vito Fazzi | Lecce | Italy |
| Azienda Ospedaliera Policlinico | Modena | Italy |
| AO Arcispedale S.Maria Nuova Ematologia | Reggio Emilia | Italy |
| Ospedale civile DH oncologico | Sassuolo (MO) | Italy |
| Ospedale San Giovanni Battista - Molinette | Torino | Italy |
| Derived |
| Merli F, Luminari S, Rossi G, Mammi C, Marcheselli L, Tucci A, Ilariucci F, Chiappella A, Musso M, Di Rocco A, Stelitano C, Alvarez I, Baldini L, Mazza P, Salvi F, Arcari A, Fragasso A, Gobbi PG, Liberati AM, Federico M. Cyclophosphamide, doxorubicin, vincristine, prednisone and rituximab versus epirubicin, cyclophosphamide, vinblastine, prednisone and rituximab for the initial treatment of elderly "fit" patients with diffuse large B-cell lymphoma: results from the ANZINTER3 trial of the Intergruppo Italiano Linfomi. Leuk Lymphoma. 2012 Apr;53(4):581-8. doi: 10.3109/10428194.2011.621565. Epub 2011 Nov 15. |
| 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 |
|---|---|
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D011241 | Prednisone |
| D015251 | Epirubicin |
| D014747 | Vinblastine |
| D000069283 | Rituximab |
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| 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 |
| 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 |
| 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 |
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