Overview

This trial is active, not recruiting.

Condition diffuse large b-cell lymphoma
Treatment rminichop
Phase phase 2
Sponsor Lymphoma Study Association
Start date April 2006
End date April 2010
Trial size 150 participants
Trial identifier NCT01087424, LNH03-7B

Summary

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Induction : 3 cycles every 3 weeks Consolidation :3 cycles every 3 weeks
rminichop
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

Measure
Evaluating efficacy of R-miniCHOP by overall survival
time frame: 2 years overall survival

Secondary Outcomes

Measure
Evaluating R-miniCHOP efficacy by Event free survival
time frame: 2 years event free survival

Eligibility Criteria

Male or female participants at least 80 years old.

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.

Additional Information

Official 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
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by Lymphoma Study Association.