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ACVBP Plus Rituximab in Patients Aged From 18 to 59 Years With High-risk Diffuse Large B-cell Lymphoma

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ClinicalTrials.gov Identifier: NCT00144807
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : September 2, 2015
Sponsor:
Information provided by (Responsible Party):
Lymphoma Study Association

Tracking Information
First Submitted Date  ICMJE September 2, 2005
First Posted Date  ICMJE September 5, 2005
Last Update Posted Date September 2, 2015
Study Start Date  ICMJE December 2003
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2015)
Complete remission rate (CR + CRu) [ Time Frame: 12 weeks ]
4 cycles of ACVBP
Original Primary Outcome Measures  ICMJE
 (submitted: September 2, 2005)
Complete remission rate (CR + CRu) after 4 cycles of R-ACVBP
Change History Complete list of historical versions of study NCT00144807 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2009)
Event-free survival and overall survival of patients submitted to autologous transplant and of the entire study population [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2005)
  • Overall response rate and safety after 4 cycles R-ACVBP
  • Overall response rate at the end of treatment and safety of autologous transplant.
  • Event-free survival and overall survival of patients submitted to autologous transplant and of the entire study population
  • PBSC harvest after R-ACVBP as measured by the number of CD34 positive cells
  • Number of patients who are eligible for autologous transplant and who receive it
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ACVBP Plus Rituximab in Patients Aged From 18 to 59 Years With High-risk Diffuse Large B-cell Lymphoma
Official Title  ICMJE Study of ACVBP Plus Rituximab in Previously Untreated Patients Aged From 18 to 59 Years With High Risk Diffuse Large B-cell Lymphoma (Age-adjusted IPI = 2-3)
Brief Summary This study is a multicentric trial evaluating the efficacy of R-ACVBP in patients aged 18 to 59 years with high risk diffuse large B-cell lymphoma
Detailed Description

This phase II non randomized study is based on the results of the LNH 98-5, LNH 87-2, LNH 93-3 and LNH 98-3B studies.

To date, the ACVBP regimen is considered as the reference induction treatment of the GELA in patients with 2-3 adverse prognostic factors. Indeed neither NCVBP regimen (LNH87-2) nor ECVBP (LNH93-3) led to increase the complete remission rate. More recently, the addition of etoposide to doxorubicin and cyclophosphamide (LNH98-3B) did not enhanced the complete remission rate with more toxicity. In patients < 60 years with 2-3 adverse prognostic factors the complete remission rate remained less than 65% in all these studies. Consequently, increasing the quality of response remains a major goal in this group of young patients with adverse prognostic factors.

It has been shown that the addition of rituximab to CHOP regimen significantly improved the CR rate in elderly patients with previously untreated large B-cell lymphoma when compared with CHOP alone without additional toxicities. Moreover, event-free survival and overall survival were found to be longer in the R-CHOP group. The present trial will evaluate the response rate obtained after four cycles of ACVBP combined to rituximab (R-ACVBP) before high dose therapy consolidative treatment in this group of higher risk patients.

The LNH87-2 study has shown that intensive consolidation treatment with autologous stem cell support was beneficial to high risk patients in good response after a full induction phase. The long-term results of this randomised study prompted us to consider high dose therapy as the best consolidative option for these patients.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diffuse Large Cell Lymphoma
Intervention  ICMJE
  • Drug: rituximab
  • Drug: doxorubicin
  • Drug: cyclophosphamide
  • Procedure: autologous stem cell transplantation
Study Arms  ICMJE Experimental: R-AC
rituximab + doxorubicin + cyclophosphamide + autologous stem cell transplantation
Interventions:
  • Drug: rituximab
  • Drug: doxorubicin
  • Drug: cyclophosphamide
  • Procedure: autologous stem cell transplantation
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: September 1, 2015)
128
Original Enrollment  ICMJE
 (submitted: September 2, 2005)
150
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date September 2008   (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).

Age from 18 to 59 years, eligible for transplant. Patient not previously treated. Age adjusted IPI = 2 or 3 With a minimum life expectancy of 3 months Negative HIV, HBV and HCV serologies < 4 weeks (except after vaccination). Having signed a written informed consent.

Exclusion Criteria:

Any history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed and having a diffuse large B-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included.

Central nervous system or meningeal involvement by lymphoma. Contra-indication to any drug contained in the chemotherapy regimens. Poor renal function (creatinin level >150 mmol/l), poor hepatic function (total bilirubin level >30 mmol/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.

Any serious active disease (according to the investigator's decision). Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.

Pregnant or lactating women Adult patient under tutelage.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00144807
Other Study ID Numbers  ICMJE LNH03-3B
Has Data Monitoring Committee Yes
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
Principal Investigator: Olivier Fitoussi, MD Lymphoma Study Association
Study Director: Christian Gisselbrecht, MD Lymphoma Study Association
Study Chair: Corinne Haioun, MD Lymphoma Study Association
Study Chair: Hervé Tilly, MD Lymphoma Study Association
PRS Account Lymphoma Study Association
Verification Date September 2015

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