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

August 26, 2025 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

222

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21000
        • René Olivier Casasnovas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 inductive cycles with R-ACVBP14 or R-CHOP14

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2 cycles and 4 cycles Induction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Bertrand Coiffier, MD, Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

July 5, 2007

First Submitted That Met QC Criteria

July 5, 2007

First Posted (Estimated)

July 9, 2007

Study Record Updates

Last Update Posted (Estimated)

September 3, 2025

Last Update Submitted That Met QC Criteria

August 26, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007.462

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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