Mini-CHOP and Rituximab in Patients Aged Over 80 Years

August 22, 2019 updated by: Lymphoma Study Association

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2

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

80 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: R mini CHOP
Induction : 3 cycles every 3 weeks Consolidation :3 cycles every 3 weeks
Drug: R mini CHOP
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluating efficacy of R-miniCHOP by overall survival
Time Frame: 2 years overall survival
2 years overall survival

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluating R-miniCHOP efficacy by Event free survival
Time Frame: 2 years event free survival
2 years event free survival

Collaborators and Investigators

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

Sponsor

Lymphoma Study Association

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

April 1, 2006

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

August 26, 2009

First Submitted That Met QC Criteria

March 15, 2010

First Posted (Estimate)

March 16, 2010

Study Record Updates

Last Update Posted (Actual)

August 26, 2019

Last Update Submitted That Met QC Criteria

August 22, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LNH03-7B

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.

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