Lymphoma, Large-Cell, DiffusePhase 3NCT00135499
R-ACVBP Versus R-CHOP in Patients Aged 60-65 With Diffuse Large B-cell Lymphoma
A Phase 3 study testing Rituximab, Doxorubicin and Cyclophosphamide in people with Lymphoma, Large-Cell, Diffuse, run by Lymphoma Study Association at 8 sites in 3 countries.
Trial summary
The primary objective of this study is to evaluate the efficacy of doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (ACVBP) plus rituximab in comparison to cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) plus rituximab in patients aged from 60 to 65 years with non-previously treated… Read more about this study
- Who is it for?
- Ages 60 to 65 years
- Conditions the study is for
- Lymphoma, Large-Cell, Diffuse
- What is being tested?
- Rituximab, Doxorubicin and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 16 Oct 2001to 27 Apr 2010
- Phase
- Phase 3
- 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 60 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with diffuse large B-cell lymphoma according to the WHO classification (anti CD20 labeling)
- Aged from 60 to 65 years.
- Not previously treated.
- Ann Arbor stage II, III, IV.
- ECOG performance status 0 to 2.
- Minimum life expectancy of 3 months.
- Negative HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV) serologies test 4 weeks (except after vaccination).
- Having previously signed a written informed consent.
Who cannot join
- T-cell 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.
- Any serious active disease (according to the investigator's decision).
- Poor renal function (creatinine level>150micromol/l), poor hepatic function (total bilirubin level>30mmol/l, transaminases>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
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- Poor bone marrow reserve as defined by neutrophils<1.5G/l or platelets<100G/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.
- Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
- Adult patient under tutelage.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
France6 sites
Hôpital Henri Mondor
Créteil, 94010
Hôpital Saint Louis
Paris, 75010
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69495
Centre Hospitalier Robert Debré
Reims, 51092
Centre Henri Becquerel
Rouen, 76038
Institut Gustave Roussy
Villejuif
Switzerland1 site
Schweirische Arbeitsgruppe fur klinische Krebsforschung
Lausanne
About this study
Official title: Randomized Study of ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Non Previously Treated Patients Aged From 60 to 65 Years With Diffuse Large B-Cell Lymphoma
The primary objective of this study is to evaluate the efficacy of doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (ACVBP) plus rituximab in comparison to cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) plus rituximab in patients aged from 60 to 65 years with non-previously treated diffuse large B-cell lymphoma as measured by the event-free survival. The goal is to obtain a 10% increase of event-free survival at 3 years.
Read the detailed description
In Europe, 50% or more of new non-Hodgkin lymphoma cases occur in patients older than 60 years. More than 30% are diffuse large B-cell lymphomas (DLCL).
The CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone) was considered as the standard treatment in this population. Nevertheless, this treatment is associated with some toxic events in elderly patients and it did does not succeed to increase the 3-year survival rate above 40%.
Two trials in patients above 60 years with DLCL cases were conducted by the GELA in the aim to improve the results of CHOP.
Protocol LNH 93-5 : The primary objective of this study was to compare CHOP to ACVBP in patients aged from 61 to 69 years with aggressive lymphoma and at least one adverse prognostic factor according to the International Prognostic Index.
Unlike the CHOP regimen, the ACVBP regimen includes a more intensive induction followed by a sequential consolidation with drugs different from those used during the induction phase, and includes a prevention of neuromeningeal relapses.
Out of 708 patients included in this study, the results have shown that:
- Complete response rate was the same in the two arms.
- Event free survival was significantly better in the ACVBP arm than the CHOP arm ( 5-year survival rate : 39% versus 29%, p=0.005).
- Overall survival was significantly better in the ACVBP arm than in the CHOP arm (the 5-year survival rate : 46% versus 38%, p=0.036).
- The ACVBP regimen was more toxic than the CHOP regimen, particularly in elderly patients (> 65 years) and in patients with a low performance status.
- Prevention of neuromeningeal relapses was necessary for these patients.
Protocol LNH 98-5, the objective of this study was to compare the association CHOP + rituximab (R-CHOP) to the CHOP regimen alone in elderly patients with non previously treated diffuse large B-cell lymphoma.
Long-term results based on data from 399 patients, with a median follow-up of 5 years were as follows :
- Complete response rate was better in the R-CHOP arm than in the CHOP arm (76% versus 61%, p<0.005).
- Significant prolongation of event-free survival (p<0.0002) and overall survival (p<0.0073) in the R-CHOP arm.
- No significant difference between the two arms in terms of toxicity. R-CHOP is now considered worldwide as the standard combination for these patients.
These conclusions invited us to propose a randomized trial comparing ACVBP + rituximab to CHOP + rituximab. The study population is limited to patients aged from 60 to 65 years.
- Conditions
- Lymphoma, Large-Cell, Diffuse
- Being tested
- Rituximab, Doxorubicin, Cyclophosphamide, Vindesine, Bleomycin
- Keywords
- Lymphoma, chemotherapy, rituximab
- Medical subject headings
- 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.
RituximabDrug
375 mg/m², D1, 4 cycles
DoxorubicinDrug
75 mg/m², D1, 4 cycles
CyclophosphamideDrug
1200 mg/m², D1, 4 cycles
VindesineDrug
2 mg/m², D1, D5, 4 cycles
BleomycinDrug
10 mg, D1, D5, 4 cycles
PrednisoneDrug
60 mg, D1-D5, 4 cycles
PrednisoneDrug
40 mg, D1-D5, 4 cycles
DoxorubicinDrug
50 mg/m², D1, 4 cycles
CyclophosphamideDrug
750 mg/m², D1, 4 cycles
VincristineDrug
1.4 mg/m², D1, 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| R-ACVBP | Experimental | Rituximab, Doxorubicin, Cyclophosphamide, Vindesine, Bleomycin, Prednisone Receives: Drug: Rituximab; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Vindesine; Drug: Bleomycin; Drug: Prednisone |
| R-CHOP | Active comparator | Rituximab, Doxorubicin, Cyclophosphamide, Vincristine, Prednisone Receives: Drug: Rituximab; Drug: Prednisone; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Vincristine |
What is being measured
The primary outcome is the main question the study is designed to answer.
event free survival
percentage of patients alive with no event
Measured: 8 years (end of study)
Secondary outcomes (7)
complete response rate
percentage of patients with complete response
Measured: 8 years (end of study)
progression rate
percentage of patients with progression
Measured: 8 years (end of study)
relapse rate
percentage of patients with relapse
Measured: 8 years (end of study)
disease-free survival for complete responders
percentage of patients with complete response who remain disease-free
Measured: 8 years (end of study)
overall survival
percentage of patients alive
Measured: 8 years (end of study)
neuromeningeal relapse rate
percentage of patients with neuromeningeal relapse
Measured: 8 years (end of study)
number of SAE
Measured: 8 years (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study start16 Oct 2001
- Primary completion27 Apr 2010
- Study completion27 Apr 2010
Why it stopped: Recruitment too low
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, Large-Cell, DiffuseStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lymphoma Study Association
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation ARC
- Responsible party
- Sponsor
- Investigators
- Herve Tilly, MD, Principal investigator, Lymphoma Study Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135499
- Sponsor's protocol ID
- LNH01-5B
- Status last verified
- Aug 2018
- First submitted
- 25 Aug 2005
- Last updated
- 23 Aug 2018
- Results posted
- No
Publications
Tilly H, Lepage E, Coiffier B, Blanc M, Herbrecht R, Bosly A, Attal M, Fillet G, Guettier C, Molina TJ, Gisselbrecht C, Reyes F; Groupe d'Etude des Lymphomes de l'Adulte. Intensive conventional chemotherapy (ACVBP regimen) compared with standard CHOP for poor-prognosis aggressive non-Hodgkin lymphoma. Blood. 2003 Dec 15;102(13):4284-9. doi: 10.1182/blood-2003-02-0542. Epub 2003 Aug 14.
PubMed 12920037Coiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, Morel P, Van Den Neste E, Salles G, Gaulard P, Reyes F, Lederlin P, Gisselbrecht C. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002 Jan 24;346(4):235-42. doi: 10.1056/NEJMoa011795.
PubMed 11807147Ghesquieres H, Larrabee BR, Haioun C, Link BK, Verney A, Slager SL, Ketterer N, Ansell SM, Delarue R, Maurer MJ, Fitoussi O, Habermann TM, Peyrade F, Dogan A, Molina TJ, Novak AJ, Tilly H, Cerhan JR, Salles G. FCGR3A/2A polymorphisms and diffuse large B-cell lymphoma outcome treated with immunochemotherapy: a meta-analysis on 1134 patients from two prospective cohorts. Hematol Oncol. 2017 Dec;35(4):447-455. doi: 10.1002/hon.2305. Epub 2016 Jun 10.
PubMed 27282998Copie-Bergman C, Cuilliere-Dartigues P, Baia M, Briere J, Delarue R, Canioni D, Salles G, Parrens M, Belhadj K, Fabiani B, Recher C, Petrella T, Ketterer N, Peyrade F, Haioun C, Nagel I, Siebert R, Jardin F, Leroy K, Jais JP, Tilly H, Molina TJ, Gaulard P. MYC-IG rearrangements are negative predictors of survival in DLBCL patients treated with immunochemotherapy: a GELA/LYSA study. Blood. 2015 Nov 26;126(22):2466-74. doi: 10.1182/blood-2015-05-647602. Epub 2015 Sep 15.
PubMed 26373676
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Non Previously Treated Patients Aged From 60 to 65 Years With Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00135499
- Acronym / sponsor ID
- LNH01-5B
- Conditions
- Lymphoma, Large-Cell, Diffuse
- Keywords
- Lymphoma, chemotherapy, rituximab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment too low
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Lymphoma Study AssociationUniversity, hospital or other
- Collaborators
- Fondation ARC
- Study start
- 16 Oct 2001 (actual)
- Primary completion
- 27 Apr 2010 (actual)
- Study completion
- 27 Apr 2010 (actual)
- First posted
- 26 Aug 2005 (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.
The primary objective of this study is to evaluate the efficacy of doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (ACVBP) plus rituximab in comparison to cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) plus rituximab in patients aged from 60 to 65 years with non-previously treated diffuse large B-cell lymphoma as measured by the event-free survival. The goal is to obtain a 10% increase of event-free survival at 3 years.
Detailed description
In Europe, 50% or more of new non-Hodgkin lymphoma cases occur in patients older than 60 years. More than 30% are diffuse large B-cell lymphomas (DLCL).
The CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone) was considered as the standard treatment in this population. Nevertheless, this treatment is associated with some toxic events in elderly patients and it did does not succeed to increase the 3-year survival rate above 40%.
Two trials in patients above 60 years with DLCL cases were conducted by the GELA in the aim to improve the results of CHOP.
Protocol LNH 93-5 : The primary objective of this study was to compare CHOP to ACVBP in patients aged from 61 to 69 years with aggressive lymphoma and at least one adverse prognostic factor according to the International Prognostic Index.
Unlike the CHOP regimen, the ACVBP regimen includes a more intensive induction followed by a sequential consolidation with drugs different from those used during the induction phase, and includes a prevention of neuromeningeal relapses.
Out of 708 patients included in this study, the results have shown that:
- Complete response rate was the same in the two arms.
- Event free survival was significantly better in the ACVBP arm than the CHOP arm ( 5-year survival rate : 39% versus 29%, p=0.005).
- Overall survival was significantly better in the ACVBP arm than in the CHOP arm (the 5-year survival rate : 46% versus 38%, p=0.036).
- The ACVBP regimen was more toxic than the CHOP regimen, particularly in elderly patients (> 65 years) and in patients with a low performance status.
- Prevention of neuromeningeal relapses was necessary for these patients.
Protocol LNH 98-5, the objective of this study was to compare the association CHOP + rituximab (R-CHOP) to the CHOP regimen alone in elderly patients with non previously treated diffuse large B-cell lymphoma.
Long-term results based on data from 399 patients, with a median follow-up of 5 years were as follows :
- Complete response rate was better in the R-CHOP arm than in the CHOP arm (76% versus 61%, p<0.005).
- Significant prolongation of event-free survival (p<0.0002) and overall survival (p<0.0073) in the R-CHOP arm.
- No significant difference between the two arms in terms of toxicity. R-CHOP is now considered worldwide as the standard combination for these patients.
These conclusions invited us to propose a randomized trial comparing ACVBP + rituximab to CHOP + rituximab. The study population is limited to patients aged from 60 to 65 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R-ACVBP | Experimental | Drug: Rituximab, Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: Vindesine, Drug: Bleomycin, Drug: PrednisoneRituximab, Doxorubicin, Cyclophosphamide, Vindesine, Bleomycin, Prednisone |
| R-CHOP | Active comparator | Drug: Rituximab, Drug: Prednisone, Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: VincristineRituximab, Doxorubicin, Cyclophosphamide, Vincristine, Prednisone |
Who may qualify
- Ages
- 60 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient with diffuse large B-cell lymphoma according to the WHO classification (anti CD20 labeling)
- Aged from 60 to 65 years.
- Not previously treated.
- Ann Arbor stage II, III, IV.
- ECOG performance status 0 to 2.
Key exclusion criteria (10 listed)
- T-cell 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.
- Any serious active disease (according to the investigator's decision).
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 |
|---|---|---|
| Rituximab375 mg/m², D1, 4 cycles | Drug | R-ACVBP, R-CHOP |
| Doxorubicin75 mg/m², D1, 4 cycles | Drug | R-ACVBP |
| Cyclophosphamide1200 mg/m², D1, 4 cycles | Drug | R-ACVBP |
| Vindesine2 mg/m², D1, D5, 4 cycles | Drug | R-ACVBP |
| Bleomycin10 mg, D1, D5, 4 cycles | Drug | R-ACVBP |
| Prednisone60 mg, D1-D5, 4 cycles | Drug | R-ACVBP |
| Prednisone40 mg, D1-D5, 4 cycles | Drug | R-CHOP |
| Doxorubicin50 mg/m², D1, 4 cycles | Drug | R-CHOP |
| Cyclophosphamide750 mg/m², D1, 4 cycles | Drug | R-CHOP |
| Vincristine1.4 mg/m², D1, 4 cycles | Drug | R-CHOP |
Primary outcome
event free survival
Time frame: 8 years (end of study)
percentage of patients alive with no event
7 secondary outcomes
complete response rate
Time frame: 8 years (end of study)
progression rate
Time frame: 8 years (end of study)
relapse rate
Time frame: 8 years (end of study)
disease-free survival for complete responders
Time frame: 8 years (end of study)
overall survival
Time frame: 8 years (end of study)
neuromeningeal relapse rate
Time frame: 8 years (end of study)
number of SAE
Time frame: 8 years (end of study)
Results and safety
The study was stopped early (reason given: Recruitment too low). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Background: PubMed 12920037Tilly H, Lepage E, Coiffier B, Blanc M, Herbrecht R, Bosly A, Attal M, Fillet G, Guettier C, Molina TJ, Gisselbrecht C, Reyes F; Groupe d'Etude des Lymphomes de l'Adulte. Intensive conventional chemotherapy (ACVBP regimen) compared with standard CHOP for poor-prognosis aggressive non-Hodgkin lymphoma. Blood. 2003 Dec 15;102(13):4284-9. doi: 10.1182/blood-2003-02-0542. Epub 2003 Aug 14.
- Background: PubMed 11807147Coiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, Morel P, Van Den Neste E, Salles G, Gaulard P, Reyes F, Lederlin P, Gisselbrecht C. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002 Jan 24;346(4):235-42. doi: 10.1056/NEJMoa011795.
- Derived from this study: PubMed 27282998Ghesquieres H, Larrabee BR, Haioun C, Link BK, Verney A, Slager SL, Ketterer N, Ansell SM, Delarue R, Maurer MJ, Fitoussi O, Habermann TM, Peyrade F, Dogan A, Molina TJ, Novak AJ, Tilly H, Cerhan JR, Salles G. FCGR3A/2A polymorphisms and diffuse large B-cell lymphoma outcome treated with immunochemotherapy: a meta-analysis on 1134 patients from two prospective cohorts. Hematol Oncol. 2017 Dec;35(4):447-455. doi: 10.1002/hon.2305. Epub 2016 Jun 10.
- Derived from this study: PubMed 26373676Copie-Bergman C, Cuilliere-Dartigues P, Baia M, Briere J, Delarue R, Canioni D, Salles G, Parrens M, Belhadj K, Fabiani B, Recher C, Petrella T, Ketterer N, Peyrade F, Haioun C, Nagel I, Siebert R, Jardin F, Leroy K, Jais JP, Tilly H, Molina TJ, Gaulard P. MYC-IG rearrangements are negative predictors of survival in DLBCL patients treated with immunochemotherapy: a GELA/LYSA study. Blood. 2015 Nov 26;126(22):2466-74. doi: 10.1182/blood-2015-05-647602. Epub 2015 Sep 15.
- Official site of the Groupe d'Etudes des Lymphomes de l'Adulte (In french)Link 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.
Herve Tilly, MD principal investigator
Lymphoma Study Association
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rituximab, Doxorubicin and Cyclophosphamide in people with Lymphoma, Large-Cell, Diffuse, run by Lymphoma Study Association at 8 sites in 3 countries.
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 10 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: stopped early, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Belgium, Switzerland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Recruitment too low). Results are not available in the source record.
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?
event free survival (time frame: 8 years (end of study)). 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 NCT00135499, 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 23 Aug 2018.