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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00498043
First received: July 5, 2007
Last updated: January 14, 2014
Last verified: January 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Enrollment: 222
Study Start Date: July 2007
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (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

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided by Hospices Civils de Lyon

Additional 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
Study First Received: July 5, 2007
Last Updated: January 14, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 20, 2014