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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00498043
First Posted: July 9, 2007
Last Update Posted: August 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospices Civils de Lyon
  Purpose
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.

Condition Intervention Phase
Lymphoma, B-Cell Lymphoma, Large-Cell, Diffuse Drug: R-CHOP14 induction regimen Drug: R-ACVBP14 induction regimen Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 222
Study Start Date: July 2007
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: R-CHOP-14
R-CHOP14 induction regimen
Drug: R-CHOP14 induction regimen
R-CHOP14 induction regimen
Experimental: R-ACVBP14
R-ACVBP14 induction regimen
Drug: R-ACVBP14 induction regimen
R-ACVBP14 induction regimen

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

  Eligibility

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00498043


Locations
France
René Olivier Casasnovas
Dijon, France, 21000
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Bertrand Coiffier, MD Hospices Civils de Lyon
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00498043     History of Changes
Other Study ID Numbers: 2007.462
First Submitted: July 5, 2007
First Posted: July 9, 2007
Last Update Posted: August 13, 2014
Last Verified: August 2014

Keywords provided by Hospices Civils de Lyon:
Lymphoma
PET
Chemotherapy
Rituximab

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
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents