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Mini-CHOP and Rituximab in Patients Aged Over 80 Years

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ClinicalTrials.gov Identifier: NCT01087424
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Lymphoma Study Association

Tracking Information
First Submitted Date  ICMJE August 26, 2009
First Posted Date  ICMJE March 16, 2010
Last Update Posted Date August 26, 2019
Study Start Date  ICMJE April 2006
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2010)
Evaluating efficacy of R-miniCHOP by overall survival [ Time Frame: 2 years overall survival ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2010)
Evaluating R-miniCHOP efficacy by Event free survival [ Time Frame: 2 years event free survival ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mini-CHOP and Rituximab in Patients Aged Over 80 Years
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diffuse Large B-Cell Lymphoma
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: R mini CHOP
Induction : 3 cycles every 3 weeks Consolidation :3 cycles every 3 weeks
Intervention: Drug: R mini CHOP
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2010)
150
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 80 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01087424
Other Study ID Numbers  ICMJE LNH03-7B
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lymphoma Study Association
Study Sponsor  ICMJE Lymphoma Study Association
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Lymphoma Study Association
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP