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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01148446
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : June 22, 2010
Sponsor:
Information provided by:
Fondazione Italiana Linfomi ONLUS

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).

Condition or disease Intervention/treatment Phase
Elderly Patients (>65 Years) Diffuse Large B Cell Lymphoma (DLBCL) Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone Drug: Epirubicin Drug: Vinblastine Drug: Rituximab Drug: G-CSF Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2003
Actual Primary Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: 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
Drug: Cyclophosphamide
750 mg/mq IV, day 1

Drug: Doxorubicin
50 mg/mq IV, day1

Drug: Vincristine
1,4 mg/mq (max 2 mg)IV, day 1

Drug: Prednisone
75 mg/mq IV, days 1-5

Drug: Rituximab
375 mg/mq IV, day 1

Drug: G-CSF
300 µg tot., SC; days 7-11

Experimental: 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
Drug: Cyclophosphamide
50 mg/mq IV, day 1

Drug: Prednisone
60 mg/mq IV/PO, days 1-5

Drug: Epirubicin
50 mg/mq IV, day 1

Drug: Vinblastine
5 mg/mq IV, day 1

Drug: Rituximab
375 mg/mq IV, day 1

Drug: G-CSF
300 µg tot., SC; days 7-11




Primary Outcome Measures :
  1. Event Free Survival (EFS) [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Complete Remission (CR) rate [ Time Frame: 2 years ]
  2. Disease Free Survival (DFS) [ Time Frame: 2 years ]
  3. Multidimensional Evaluation Scale for the definition of "frail" and "non frail" patients [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   66 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148446


Locations
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Italy
Ospedale di Vigevano
Vigevano, Pavia, Italy
S.C. di Ematologia, Spedali Civili
Brescia, Italy, 25123
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
Sponsors and Collaborators
Fondazione Italiana Linfomi ONLUS
Investigators
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Francesco Merli, MD, U.O.A. di Ematologia Azienda Ospedaliera S. Maria Nuova
ClinicalTrials.gov Identifier: NCT01148446    
Other Study ID Numbers: IIL ANZINTER3
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: June 22, 2010
Last Verified: June 2010
Keywords provided by Fondazione Italiana Linfomi ONLUS:
DLBCL
R-CHOP
R-CEOP
Elderly patients
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Prednisone
Cyclophosphamide
Rituximab
Doxorubicin
Vincristine
Epirubicin
Vinblastine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors