R-CHOP Versus R-mini-CEOP in Elderly Patients(>65)With DLBCL
ANZINTER3
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)
1 other identifier
interventional
226
1 country
11
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 21, 2010
CompletedFirst Posted
Study publicly available on registry
June 22, 2010
CompletedJune 22, 2010
June 1, 2010
3 years
June 21, 2010
June 21, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event Free Survival (EFS)
2 years
Secondary Outcomes (3)
Complete Remission (CR) rate
2 years
Disease Free Survival (DFS)
2 years
Multidimensional Evaluation Scale for the definition of "frail" and "non frail" patients
2 years
Study Arms (2)
R-CHOP
EXPERIMENTALR-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
EXPERIMENTALR-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
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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
- Patients HIV negativity;
- Concurrent malignancy;
- Written Informed Consent.
You may not qualify if:
- All other patients were classified as "unfit", and were excluded from randomization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
S.C. di Ematologia, Spedali Civili
Brescia, Brescia, 25123, 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
Related Publications (2)
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.
PMID: 29975624DERIVEDMerli 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.
PMID: 21895543DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
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 Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 21, 2010
First Posted
June 22, 2010
Study Start
January 1, 2003
Primary Completion
January 1, 2006
Last Updated
June 22, 2010
Record last verified: 2010-06