Mini-CHOP and Rituximab in Patients Aged Over 80 Years

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Lymphoma Study Association.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Lymphoma Study Association
ClinicalTrials.gov Identifier:
NCT01087424
First received: August 26, 2009
Last updated: March 15, 2010
Last verified: March 2010
  Purpose

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 Intervention Phase
Diffuse Large B-cell Lymphoma
Drug: RminiCHOP
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Lymphoma Study Association:

Primary Outcome Measures:
  • Evaluating efficacy of R-miniCHOP by overall survival [ Time Frame: 2 years overall survival ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluating R-miniCHOP efficacy by Event free survival [ Time Frame: 2 years event free survival ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: April 2006
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: R mini CHOP
Induction : 3 cycles every 3 weeks Consolidation :3 cycles every 3 weeks
Drug: 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

  Eligibility

Ages Eligible for Study:   80 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
No Contacts or Locations Provided
  More Information

No publications provided by Lymphoma Study Association

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Fréderic Peyrade/ Coordinating investigator, service d'hématologie- centre Antoine Lacassagne -Nice
ClinicalTrials.gov Identifier: NCT01087424     History of Changes
Other Study ID Numbers: LNH03-7B
Study First Received: August 26, 2009
Last Updated: March 15, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Lymphoma Study Association:
Diffuse Large B-Cell Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 17, 2014