R-CHOP Versus R-mini-CEOP in Elderly Patients(>65)With DLBCL
NCT ID: NCT01148446
Last Updated: 2010-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
226 participants
INTERVENTIONAL
2003-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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R-CHOP
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
Cyclophosphamide
750 mg/mq IV, day 1
Doxorubicin
50 mg/mq IV, day1
Vincristine
1,4 mg/mq (max 2 mg)IV, day 1
Prednisone
75 mg/mq IV, days 1-5
Rituximab
375 mg/mq IV, day 1
G-CSF
300 µg tot., SC; days 7-11
R-mini-CEOP
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
Cyclophosphamide
50 mg/mq IV, day 1
Prednisone
60 mg/mq IV/PO, days 1-5
Epirubicin
50 mg/mq IV, day 1
Vinblastine
5 mg/mq IV, day 1
Rituximab
375 mg/mq IV, day 1
G-CSF
300 µg tot., SC; days 7-11
Interventions
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Cyclophosphamide
750 mg/mq IV, day 1
Cyclophosphamide
50 mg/mq IV, day 1
Doxorubicin
50 mg/mq IV, day1
Vincristine
1,4 mg/mq (max 2 mg)IV, day 1
Prednisone
75 mg/mq IV, days 1-5
Prednisone
60 mg/mq IV/PO, days 1-5
Epirubicin
50 mg/mq IV, day 1
Vinblastine
5 mg/mq IV, day 1
Rituximab
375 mg/mq IV, day 1
G-CSF
300 µg tot., SC; days 7-11
Eligibility Criteria
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Inclusion Criteria
2. Patients were classified as "non frail" (fit) if they had
* ADL (Activity of Daily Living) score of 6
* less than three grade 3 Cumulative Illness Rating Score for Geriatrics (CIRS-G) co-morbidities and no grade 4 co-morbidities
* absence of geriatric syndrome
3. Patients HIV negativity;
4. Concurrent malignancy;
5. Written Informed Consent.
Exclusion Criteria
66 Years
80 Years
ALL
No
Sponsors
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Fondazione Italiana Linfomi - ETS
OTHER
Responsible Party
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U.O.A. di Ematologia Azienda Ospedaliera S. Maria Nuova
Principal Investigators
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Francesco Merli, MD
Role: STUDY_CHAIR
U.O.A. di Ematologia Azienda Ospedale S. Maria Nuova
Marilena Bertini, MD
Role: STUDY_CHAIR
U.O.A. di Ematologia Ospedale Molinette
Locations
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S.C. di Ematologia, Spedali Civili
Brescia, Brescia, Italy
Ospedale di Vigevano
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
Countries
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References
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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.
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.
Other Identifiers
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IIL ANZINTER3
Identifier Type: -
Identifier Source: org_study_id
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