Clinical trial NCT01148446: R-CHOP Versus R-mini-CEOP in Elderly Patients(>65)With DLBCL
Official title: A Randomized Phase III Randomized Study to Compare R-CHOP Versus R-mini-CEOP in Elderly Patients (>65 Years) With Diffuse Large B Cell Lymphoma (DLBCL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Elderly Patients (>65 Years)
Diffuse Large B Cell Lymphoma (DLBCL)
Keywords: DLBCL
R-CHOP
R-CEOP
Elderly patients
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 226
Sex: ALL
Minimum age (years): 66
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

1. Patients with untreated DLBCL aged 66 to 80 years without major accompanying diseases and considered as "non frail".
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:

* All other patients were classified as "unfit", and were excluded from randomization

Primary outcomes:
measure: Event Free Survival (EFS)
timeFrame: 2 years
Secondary outcomes:
measure: Complete Remission (CR) rate
timeFrame: 2 years
measure: Disease Free Survival (DFS)
timeFrame: 2 years
measure: Multidimensional Evaluation Scale for the definition of "frail" and "non frail" patients
timeFrame: 2 years
Other outcomes:
Locations:
city: Vigevano
country: Italy
facility: Ospedale di Vigevano
state: Pavia
city: Brescia
country: Italy
facility: S.C. di Ematologia, Spedali Civili
city: Catania
country: Italy
facility: Ospedale Garibaldi-Nesima
city: Civitanova Marche (MC)
country: Italy
facility: Ospedale civile Divisione di Ematologia
city: Correggio (RE)
country: Italy
facility: Ospedale San Sebastiano
city: Cosenza
country: Italy
facility: Presidio Ospedaliero Annunziata
city: Lecce
country: Italy
facility: Istituto Vito Fazzi
city: Modena
country: Italy
facility: Azienda Ospedaliera Policlinico
city: Reggio Emilia
country: Italy
facility: AO Arcispedale S.Maria Nuova Ematologia
city: Sassuolo (MO)
country: Italy
facility: Ospedale civile DH oncologico
city: Torino
country: Italy
facility: Ospedale San Giovanni Battista - Molinette
Study officials:
affiliation: U.O.A. di Ematologia Azienda Ospedale S. Maria Nuova
name: Francesco Merli, MD
role: STUDY_CHAIR
affiliation: U.O.A. di Ematologia Ospedale Molinette
name: Marilena Bertini, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.