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

June 21, 2010 updated by: Fondazione Italiana Linfomi ONLUS

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

226

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy, 25123
        • S.C. di Ematologia, Spedali Civili
      • Catania, Italy
        • Ospedale Garibaldi-Nesima
      • Civitanova Marche (MC), Italy
        • Ospedale civile Divisione di Ematologia
      • Correggio (RE), Italy
        • Ospedale San Sebastiano
      • Cosenza, Italy
        • Presidio Ospedaliero Annunziata
      • Lecce, Italy
        • Istituto Vito Fazzi
      • Modena, Italy
        • Azienda Ospedaliera Policlinico
      • Reggio Emilia, Italy
        • AO Arcispedale S.Maria Nuova Ematologia
      • Sassuolo (MO), Italy
        • Ospedale civile DH oncologico
      • Torino, Italy
        • Ospedale San Giovanni Battista - Molinette
    • Pavia
      • Vigevano, Pavia, Italy
        • Ospedale di Vigevano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

66 years to 80 years (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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: Cyclophosphamide
50 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: Prednisone
60 mg/mq IV/PO, 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
750 mg/mq IV, day 1
Drug: Cyclophosphamide
50 mg/mq IV, day 1
Drug: Prednisone
75 mg/mq IV, days 1-5
Drug: Prednisone
60 mg/mq IV/PO, days 1-5
Drug: Rituximab
375 mg/mq IV, day 1
Drug: G-CSF
300 µg tot., SC; days 7-11
Drug: Epirubicin
50 mg/mq IV, day 1
Drug: Vinblastine
5 mg/mq IV, day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Event Free Survival (EFS)
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Complete Remission (CR) rate
Time Frame: 2 years
2 years
Disease Free Survival (DFS)
Time Frame: 2 years
2 years
Multidimensional Evaluation Scale for the definition of "frail" and "non frail" patients
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Linfomi ONLUS

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (ACTUAL)

January 1, 2006

Study Registration Dates

First Submitted

June 21, 2010

First Submitted That Met QC Criteria

June 21, 2010

First Posted (ESTIMATE)

June 22, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 22, 2010

Last Update Submitted That Met QC Criteria

June 21, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIL ANZINTER3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diffuse Large B Cell Lymphoma (DLBCL)

Clinical Trials on Cyclophosphamide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe