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Completed

NCT Number: NCT01148446

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

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Key information

Conditions

Elderly Patients (>65 Years) Diffuse Large B Cell Lymphoma (DLBCL) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

66 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

S.C. di Ematologia, Spedali Civili, Brescia, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclophosphamide

Drug

750 mg/mq IV, day 1

Doxorubicin

Drug

50 mg/mq IV, day1

Vincristine

Drug

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

Prednisone

Drug

75 mg/mq IV, days 1-5

Epirubicin

Drug

50 mg/mq IV, day 1

Vinblastine

Drug

5 mg/mq IV, day 1

Rituximab

Drug

375 mg/mq IV, day 1

G-CSF

Drug

300 µg tot., SC; days 7-11

Primary outcomes

  1. Event Free Survival (EFS)

    Time frame: 2 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Fondazione Italiana Linfomi - ETS

Other

Registry information

Official study 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)

Acronym: ANZINTER3

Important dates

Study start
2003
Primary completion
2006
First posted
Jun 22, 2010
Registry last updated
Jun 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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