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OpenTrials
Completed

NCT Number: NCT01087424

Mini-CHOP and Rituximab in Patients Aged Over 80 Years

The purpose of the study is to evaluate efficacy and safety of R-miniCHOP for elderly patients with diffuse large B-Cell lymphoma (DLBC) Lymphoma aged over 80 years by measuring the overall survival.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO classification). DLBCL with some small cell infiltration in bone marrow or lymph node may be included.
  • Aged over 80 years.
  • Ann Arbor stage I bulky, II, III or IV
  • Age-adjusted International Prognostic Index equal to 0, 1, 2 and 3.
  • Patient non previously treated.
  • ECOG performance status ≤ 2.
  • With a minimum life expectancy of 3 months.
  • Negative HIV, HBV and HCV serologies test ≤ 4 weeks (except after vaccination).
  • Having previously signed a written informed consent

Exclusion criteria

  • Any other histological type of lymphoma.
  • Any history of treated or non-treated indolent lymphoma.
  • Central nervous system or meningeal involvement by lymphoma.
  • Contra-indication to any drug contained in the chemotherapy regimens.
  • Any serious active disease (according to the investigator's decision).
  • Poor renal function (creatinin level>150µmol/l), poor hepatic function (total bilirubin level>30mmol/l, transaminases>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
  • Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100 G/l, unless related to bone marrow infiltration.
  • Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
  • Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
  • Adult patient under tutelage.

Treatment and study plan

R mini CHOP

Drug

Prednisone 40 mg/m2 D1 D2 D3 D4 D5 Rituximab 375 mg/m2 D1 Doxorubicine 25 mg/m2 D1 Cyclophosphamide 400 mg/m2 D1 Vincristine 1 mg/m2 D1

Primary outcomes

  1. Evaluating efficacy of R-miniCHOP by overall survival

    Time frame: 2 years overall survival

Secondary outcomes

  1. Evaluating R-miniCHOP efficacy by Event free survival

    Time frame: 2 years event free survival

Sponsors and collaborators

Lead sponsor

Lymphoma Study Association

Other

Registry information

Official study title

Phase II Study of Mini-CHOP Plus Rituximab in Non Previously Treated Patients Aged Over 80 Years With CD 20+ Diffuse Large B-Cell Lymphoma

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Mar 16, 2010
Registry last updated
Aug 26, 2019

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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