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R-CHOP Versus R-mini-CEOP in Elderly Patients(>65)With DLBCL (ANZINTER3)

Primary Purpose

Elderly Patients (>65 Years), Diffuse Large B Cell Lymphoma (DLBCL)

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Cyclophosphamide
Cyclophosphamide
Doxorubicin
Vincristine
Prednisone
Prednisone
Epirubicin
Vinblastine
Rituximab
G-CSF
Sponsored by
Fondazione Italiana Linfomi - ETS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elderly Patients (>65 Years) focused on measuring DLBCL, R-CHOP, R-CEOP, Elderly patients

Eligibility Criteria

66 Years - 80 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale di Vigevano
  • S.C. di Ematologia, Spedali Civili
  • Ospedale Garibaldi-Nesima
  • Ospedale civile Divisione di Ematologia
  • Ospedale San Sebastiano
  • Presidio Ospedaliero Annunziata
  • Istituto Vito Fazzi
  • Azienda Ospedaliera Policlinico
  • AO Arcispedale S.Maria Nuova Ematologia
  • Ospedale civile DH oncologico
  • Ospedale San Giovanni Battista - Molinette

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

R-CHOP

R-mini-CEOP

Arm Description

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-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

Outcomes

Primary Outcome Measures

Event Free Survival (EFS)

Secondary Outcome Measures

Complete Remission (CR) rate
Disease Free Survival (DFS)
Multidimensional Evaluation Scale for the definition of "frail" and "non frail" patients

Full Information

First Posted
June 21, 2010
Last Updated
June 21, 2010
Sponsor
Fondazione Italiana Linfomi - ETS
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1. Study Identification

Unique Protocol Identification Number
NCT01148446
Brief Title
R-CHOP Versus R-mini-CEOP in Elderly Patients(>65)With DLBCL
Acronym
ANZINTER3
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

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Fondazione Italiana Linfomi - ETS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly Patients (>65 Years), Diffuse Large B Cell Lymphoma (DLBCL)
Keywords
DLBCL, R-CHOP, R-CEOP, Elderly patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
R-CHOP
Arm Type
Experimental
Arm Description
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
Arm Title
R-mini-CEOP
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
750 mg/mq IV, day 1
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
50 mg/mq IV, day 1
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
50 mg/mq IV, day1
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
1,4 mg/mq (max 2 mg)IV, day 1
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
75 mg/mq IV, days 1-5
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
60 mg/mq IV/PO, days 1-5
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Intervention Description
50 mg/mq IV, day 1
Intervention Type
Drug
Intervention Name(s)
Vinblastine
Intervention Description
5 mg/mq IV, day 1
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
375 mg/mq IV, day 1
Intervention Type
Drug
Intervention Name(s)
G-CSF
Intervention Description
300 µg tot., SC; days 7-11
Primary Outcome Measure Information:
Title
Event Free Survival (EFS)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Complete Remission (CR) rate
Time Frame
2 years
Title
Disease Free Survival (DFS)
Time Frame
2 years
Title
Multidimensional Evaluation Scale for the definition of "frail" and "non frail" patients
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
66 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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. Exclusion Criteria: All other patients were classified as "unfit", and were excluded from randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Merli, MD
Organizational Affiliation
U.O.A. di Ematologia Azienda Ospedale S. Maria Nuova
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marilena Bertini, MD
Organizational Affiliation
U.O.A. di Ematologia Ospedale Molinette
Official's Role
Study Chair
Facility Information:
Facility Name
Ospedale di Vigevano
City
Vigevano
State/Province
Pavia
Country
Italy
Facility Name
S.C. di Ematologia, Spedali Civili
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Ospedale Garibaldi-Nesima
City
Catania
Country
Italy
Facility Name
Ospedale civile Divisione di Ematologia
City
Civitanova Marche (MC)
Country
Italy
Facility Name
Ospedale San Sebastiano
City
Correggio (RE)
Country
Italy
Facility Name
Presidio Ospedaliero Annunziata
City
Cosenza
Country
Italy
Facility Name
Istituto Vito Fazzi
City
Lecce
Country
Italy
Facility Name
Azienda Ospedaliera Policlinico
City
Modena
Country
Italy
Facility Name
AO Arcispedale S.Maria Nuova Ematologia
City
Reggio Emilia
Country
Italy
Facility Name
Ospedale civile DH oncologico
City
Sassuolo (MO)
Country
Italy
Facility Name
Ospedale San Giovanni Battista - Molinette
City
Torino
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
29975624
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.
Results Reference
derived
PubMed Identifier
21895543
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.
Results Reference
derived

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R-CHOP Versus R-mini-CEOP in Elderly Patients(>65)With DLBCL

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