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A Study of Two Associations of Rituximab and Chemotherapy, With a PET-driven Strategy, in Lymphoma (LNH2007-3B)

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ClinicalTrials.gov Identifier: NCT00498043
Recruitment Status : Completed
First Posted : July 9, 2007
Last Update Posted : August 13, 2014
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE July 5, 2007
First Posted Date  ICMJE July 9, 2007
Last Update Posted Date August 13, 2014
Study Start Date  ICMJE July 2007
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2011)
Complete response rate after 4 inductive cycles with R-ACVBP14 or R-CHOP14, in DLBCL CD 20 (+) patients, presenting with 2 or 3 adverse prognostic factors of the aa-IPI Test a Pet-driven strategy Complete response rate after the 4 inductive cycles [ Time Frame: 4 inductive cycles with R-ACVBP14 or R-CHOP14 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 5, 2007)
Complete response rate after 4 inductive cycles with R-ACVBP14 or R-CHOP14, in DLBCL CD 20 (+) patients, presenting with 2 or 3 adverse prognostic factors of the aa-IPI Test a Pet-driven strategy Complete response rate after the 4 inductive cycles
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2011)
Response according to PET after 2 cycles, 4 cycles Induction toxicities Response duration Disease-, progression-, event-free and overall survival after autologous transplant Biological factors for prognosis Pharmacokinetic of rituximab [ Time Frame: 2 cycles and 4 cycles Induction ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2007)
Response according to PET after 2 cycles, 4 cycles Induction toxicities Response duration Disease-, progression-, event-free and overall survival after autologous transplant Biological factors for prognosis Pharmacokinetic of rituximab
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Two Associations of Rituximab and Chemotherapy, With a PET-driven Strategy, in Lymphoma
Official Title  ICMJE Randomized Phase II Study of Two Associations of Rituximab and Chemotherapy, With a PET -Driven Strategy, in Patients From 18 to 59 With DLBCL CD20+ Lymphoma and 2 or 3 Adverse Prognostic Factors of the Age-adjusted IPI
Brief Summary This Phase II study randomized R-ACVBP and R-CHOP as induction treatment in patients from 18 to 59 with DLBCL CD20+ lymphoma and 2 or 3 adverse prognostic factors of the age-adjusted IPI. The consolidation treatment is allocated according to the response to induction treatment assessed by PET after the 2nd and 4th induction cycles.
Detailed Description

1) Induction Arm A: 4 cycles of R-ACVBP, 2 weeks interval. After the 3rd cycle, if PET 2+ (fixing), collection of peripheral blood stem cell progenitors will be organized at the time of hematological recovery under support with G-CSF.

The consolidation treatment will depend on results of PET evaluation after cycle 2 (PET2) and cycle 4 (PET4).

  • Consolidation 1A (in case of PET 2- PET 4 -):

    • High-dose Methotrexate with folinic acid rescue; 2 cycles spaced out 14 days.
    • Rituximab-Ifosfamide-Etoposide : 4 cycles spaced out 14 days
    • Cytarabine sub-cutaneous, during 4 days; 2 cycles spaced out 14 days.
  • Consolidation 2 A (in case of PET 2+ PET4 -):

    • 2 cycles high-dose Methotrexate with folinic acid rescue
    • High dose with Z- BEAM conditioning regimen followed by autologous transplant.
  • Salvage(in case of PET 4 +):

The patient will be treated with a salvage regimen, after a biopsy of the residual mass whenever possible.

2) Induction arm B: 4 cycles of R-CHOP, 2 weeks interval. After the 3rd cycle, if PET 2+ (fixing), collection of peripheral blood stem cell progenitors will be organized at the time of hematological recovery under support with G-CSF.

The consolidation treatment will depend on results of PET evaluation after cycle 2 (PET2) and cycle 4 (PET4).

  • Consolidation 1B(in case of PET 2- PET 4 -):

    4 additional cycles of R-CHOP, 2-weeks interval

  • Consolidation 2 B(in case of PET 2+ PET 4 -):

    • 2 cycles high-dose Methotrexate with folinic acid rescue
    • High dose with Z- BEAM conditioning regimen followed by autologous transplant
  • Salvage(in case of PET 4 +):

The patient will be treated with a salvage regimen, after a biopsy of the residual mass whenever possible

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphoma, B-Cell
  • Lymphoma, Large-Cell, Diffuse
Intervention  ICMJE
  • Drug: R-CHOP14 induction regimen
    R-CHOP14 induction regimen
  • Drug: R-ACVBP14 induction regimen
    R-ACVBP14 induction regimen
Study Arms  ICMJE
  • Experimental: R-CHOP-14
    R-CHOP14 induction regimen
    Intervention: Drug: R-CHOP14 induction regimen
  • Experimental: R-ACVBP14
    R-ACVBP14 induction regimen
    Intervention: Drug: R-ACVBP14 induction regimen
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: July 5, 2007)
222
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (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 from18 to 59 years, eligible for transplant.
  • Patient not previously treated.
  • Baseline FDG-PET Scan (PET0) performed before any treatment with at least one hypermetabolic lesion.
  • Index prognostic factors (IPI) 2 or 3.
  • With a minimum life expectancy of 3 months.
  • Negative HIV, HBV and HCV serologies £ 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. 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.
  • Pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception
  • Adult patient under tutelage.
  • Impossibility to performed a baseline PET scan (PET0) before randomization and treatment beginning
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 France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00498043
Other Study ID Numbers  ICMJE 2007.462
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Hospices Civils de Lyon
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Hospices Civils de Lyon
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bertrand Coiffier, MD Hospices Civils de Lyon
PRS Account Hospices Civils de Lyon
Verification Date August 2014

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