Lymphoma, B-CellPhase 2LNH2007-3BNCT00498043
A Study of Two Associations of Rituximab and Chemotherapy, With a PET-driven Strategy, in Lymphoma
A Phase 2 study testing R-CHOP14 induction regimen and R-ACVBP14 induction regimen in people with Lymphoma, B-Cell and Lymphoma, Large-Cell, Diffuse, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Lymphoma, B-Cell, Lymphoma, Large-Cell, Diffuse
- What is being tested?
- R-CHOP14 induction regimen and R-ACVBP14 induction regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2007to Oct 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
- 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.
- 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
- Conditions
- Lymphoma, B-Cell, Lymphoma, Large-Cell, Diffuse
- Being tested
- R-CHOP14 induction regimen, R-ACVBP14 induction regimen
- Keywords
- Lymphoma, PET, Chemotherapy, Rituximab
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-CHOP14 induction regimenDrug
R-CHOP14 induction regimen
R-ACVBP14 induction regimenDrug
R-ACVBP14 induction regimen
| Study group | Role | What they receive |
|---|---|---|
| R-CHOP-14 | Experimental | R-CHOP14 induction regimen Receives: Drug: R-CHOP14 induction regimen |
| R-ACVBP14 | Experimental | R-ACVBP14 induction regimen Receives: Drug: R-ACVBP14 induction regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 inductive cycles with R-ACVBP14 or R-CHOP14
Secondary outcomes (1)
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
Measured: 2 cycles and 4 cycles Induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, B-CellStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand Coiffier, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498043
- Sponsor's protocol ID
- 2007.462
- Acronym
- LNH2007-3B
- Status last verified
- Aug 2025
- First submitted
- 5 Jul 2007
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Casasnovas RO, Meignan M, Berriolo-Riedinger A, Bardet S, Julian A, Thieblemont C, Vera P, Bologna S, Briere J, Jais JP, Haioun C, Coiffier B, Morschhauser F; Groupe d'etude des lymphomes de l'adulte (GELA). SUVmax reduction improves early prognosis value of interim positron emission tomography scans in diffuse large B-cell lymphoma. Blood. 2011 Jul 7;118(1):37-43. doi: 10.1182/blood-2010-12-327767. Epub 2011 Apr 25.
PubMed 21518924Girum KB, Rebaud L, Cottereau AS, Meignan M, Clerc J, Vercellino L, Casasnovas O, Morschhauser F, Thieblemont C, Buvat I. 18F-FDG PET Maximum-Intensity Projections and Artificial Intelligence: A Win-Win Combination to Easily Measure Prognostic Biomarkers in DLBCL Patients. J Nucl Med. 2022 Dec;63(12):1925-1932. doi: 10.2967/jnumed.121.263501. Epub 2022 Jun 16.
PubMed 35710733Blanc-Durand P, Jegou S, Kanoun S, Berriolo-Riedinger A, Bodet-Milin C, Kraeber-Bodere F, Carlier T, Le Gouill S, Casasnovas RO, Meignan M, Itti E. Fully automatic segmentation of diffuse large B cell lymphoma lesions on 3D FDG-PET/CT for total metabolic tumour volume prediction using a convolutional neural network. Eur J Nucl Med Mol Imaging. 2021 May;48(5):1362-1370. doi: 10.1007/s00259-020-05080-7. Epub 2020 Oct 24.
PubMed 33097974Tout M, Casasnovas O, Meignan M, Lamy T, Morschhauser F, Salles G, Gyan E, Haioun C, Mercier M, Feugier P, Boussetta S, Paintaud G, Ternant D, Cartron G. Rituximab exposure is influenced by baseline metabolic tumor volume and predicts outcome of DLBCL patients: a Lymphoma Study Association report. Blood. 2017 May 11;129(19):2616-2623. doi: 10.1182/blood-2016-10-744292. Epub 2017 Mar 1.
PubMed 28251914
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00498043
- Acronym / sponsor ID
- LNH2007-3B / 2007.462
- Conditions
- Lymphoma, B-Cell, Lymphoma, Large-Cell, Diffuse
- Keywords
- Lymphoma, PET, Chemotherapy, Rituximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 9 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R-CHOP-14 | Experimental | Drug: R-CHOP14 induction regimenR-CHOP14 induction regimen |
| R-ACVBP14 | Experimental | Drug: R-ACVBP14 induction regimenR-ACVBP14 induction regimen |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R-CHOP14 induction regimenR-CHOP14 induction regimen | Drug | R-CHOP-14 |
| R-ACVBP14 induction regimenR-ACVBP14 induction regimen | Drug | R-ACVBP14 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Results publication: PubMed 21518924Casasnovas RO, Meignan M, Berriolo-Riedinger A, Bardet S, Julian A, Thieblemont C, Vera P, Bologna S, Briere J, Jais JP, Haioun C, Coiffier B, Morschhauser F; Groupe d'etude des lymphomes de l'adulte (GELA). SUVmax reduction improves early prognosis value of interim positron emission tomography scans in diffuse large B-cell lymphoma. Blood. 2011 Jul 7;118(1):37-43. doi: 10.1182/blood-2010-12-327767. Epub 2011 Apr 25.
- Derived from this study: PubMed 35710733Girum KB, Rebaud L, Cottereau AS, Meignan M, Clerc J, Vercellino L, Casasnovas O, Morschhauser F, Thieblemont C, Buvat I. 18F-FDG PET Maximum-Intensity Projections and Artificial Intelligence: A Win-Win Combination to Easily Measure Prognostic Biomarkers in DLBCL Patients. J Nucl Med. 2022 Dec;63(12):1925-1932. doi: 10.2967/jnumed.121.263501. Epub 2022 Jun 16.
- Derived from this study: PubMed 33097974Blanc-Durand P, Jegou S, Kanoun S, Berriolo-Riedinger A, Bodet-Milin C, Kraeber-Bodere F, Carlier T, Le Gouill S, Casasnovas RO, Meignan M, Itti E. Fully automatic segmentation of diffuse large B cell lymphoma lesions on 3D FDG-PET/CT for total metabolic tumour volume prediction using a convolutional neural network. Eur J Nucl Med Mol Imaging. 2021 May;48(5):1362-1370. doi: 10.1007/s00259-020-05080-7. Epub 2020 Oct 24.
- Derived from this study: PubMed 28251914Tout M, Casasnovas O, Meignan M, Lamy T, Morschhauser F, Salles G, Gyan E, Haioun C, Mercier M, Feugier P, Boussetta S, Paintaud G, Ternant D, Cartron G. Rituximab exposure is influenced by baseline metabolic tumor volume and predicts outcome of DLBCL patients: a Lymphoma Study Association report. Blood. 2017 May 11;129(19):2616-2623. doi: 10.1182/blood-2016-10-744292. Epub 2017 Mar 1.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertrand Coiffier, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing R-CHOP14 induction regimen and R-ACVBP14 induction regimen in people with Lymphoma, B-Cell and Lymphoma, Large-Cell, Diffuse, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00498043, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.