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Mini-CHOP and Rituximab in Patients Aged Over 80 Years

Sponsor
Lymphoma Study Association (Other)
Overall Status
Completed
CT.gov ID
NCT01087424
Collaborator
(none)
150
Enrollment
1
Arm
50
Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: R mini CHOP
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Apr 1, 2006
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Jun 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Evaluating efficacy of R-miniCHOP by overall survival [2 years overall survival]

Secondary Outcome Measures

  1. Evaluating R-miniCHOP efficacy by Event free survival [2 years event free survival]

Eligibility Criteria

Criteria

Ages Eligible for Study:
80 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Lymphoma Study Association

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lymphoma Study Association
ClinicalTrials.gov Identifier:
NCT01087424
Other Study ID Numbers:
  • LNH03-7B
First Posted:
Mar 16, 2010
Last Update Posted:
Aug 26, 2019
Last Verified:
Aug 1, 2019
Keywords provided by Lymphoma Study Association
Diffuse Large B-Cell Lymphoma
Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse

Study Results

No Results Posted as of Aug 26, 2019