Diffuse Large Cell LymphomaPhase 3NCT00140660
ACVBP Versus ACVBP Plus Rituximab in Low Risk Localized Diffuse Large B-cell Lymphoma
A Phase 3 study testing rituximab in people with Diffuse Large Cell Lymphoma, run by Lymphoma Study Association at 11 sites in 3 countries.
Trial summary
This study is a multicentric randomized trial evaluating the efficacy of the combination R-ACVBP in patients 18 to 65 years with low risk localized diffuse large B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diffuse Large Cell Lymphoma
- What is being tested?
- rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 11 sitesin 3 countries
- Study dates
- Dec 2003to Apr 2012
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO classification).
- Age from 18 to 65 years.
- Patient not previously treated.
- Ann Arbor stage I or II.
- ECOG performance status < 2.
- Normal LDH.
- 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. vAny 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 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).
- Poor bone marrow reserve as defined by neutrophils < 1.5 G/l or platelets < 100 G/l.
- Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
Show all 10Show fewer
- Any serious active disease (according to the investigator's decision).
- Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
- Pregnant or lactating women
- Adult patient under tutelage.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
France9 sites
Hôpital Henri Mondor
Créteil, 94010
Hématologie CHU de Lille
Lille, 59000
Hôpital Saint Louis
Paris, 75010
Hématologie Adultes - Hôpital Necker
Paris, 75743
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69495
Centre Hospitalier Robert Debré
Reims, 51092
Centre Henri Becquerel
Rouen, 76038
Hématologie CHU Purpan
Toulouse, 31059
Institut Gustave Roussy
Villejuif
Switzerland1 site
Centre Pluridisciplinaire d'Oncologie, CHUV
Lausanne, 1011
About this study
Official title: Randomized Study of ACVBP Versus ACVBP Plus Rituximab in Previously Untreated Patients Aged From 18 to 65 Years With Low-risk Localized Diffuse Large B-cell Lymphoma (Age-adjusted IPI = 0)
This study is a multicentric randomized trial evaluating the efficacy of the combination R-ACVBP in patients 18 to 65 years with low risk localized diffuse large B-cell lymphoma.
Read the detailed description
Approximately 30 to 40% of diffuse large B cell lymphomas are localized at diagnosis (stage I-II). Until the seventies, radiotherapy was used as the single modality to treat these localized stages but no more than half of the patients were cured. From the eighties, anthracycline-based regimens combined or not with radiotherapy gave superior results in term of relapse free survival compared with radiotherapy alone. Later on Miller et al. published a randomized study showing that 3 cycles of CHOP combined with radiotherapy gave superior results in term of overall survival as compared with 8 cycles of CHOP. This study was recently updated with a follow up of more than 8 years and shows no more difference between the two arms, due to an excess of late mortality after the combined treatment.
Recently, two trials were conducted by the GELA to compare chemotherapy alone to a combined chemo-radiotherapy approach in patients with low risk localized diffuse large cell lymphoma (age-adjusted IPI = 0).
- The objective of the LNH 93-1 study was to compare, in patients aged from 18 to 60 years 3 cycles of CHOP followed by radiotherapy with chemotherapy alone consisting in 3 cycles of ACVBP. The ACVBP regimen includes a more intensive induction followed by a sequential consolidation. With a median follow up of 55 months, the results have shown a superiority of the ACVBP arm for both the 5 year event free (83% vs. 74%, p = 0.004) and overall survival (89% vs. 80%, p = 0.02).
- The LNH 93-4 study compared in patients >60 years the association of 4 cycles of CHOP + radiotherapy to the same regimen without irradiation. This study fails to demonstrate any benefit of the combined chemo-radiotherapy in term of survival, but indicates that chemotherapy alone is probably less toxic in patients older than 69 years.
Considering these two trials, we concluded that radiotherapy given after chemotherapy did not give any benefit to elderly patients treated for a low risk localized diffuse large cell lymphoma, and that ACVBP regimen was superior to 3 CHOP + radiotherapy in patients <60 years, and has to be considered as the treatment of reference in these patients.
Two other GELA trials contributed recently to improve the treatment of diffuse large B cell lymphoma and have to be considered for the elaboration of future studies:
- The objective of the LNH 98-5 study was to compare the association of CHOP + rituximab (R-CHOP) to the CHOP regimen alone in elderly patients with previously untreated large B-cell lymphoma. The analysis showed a significant superiority of the association CHOP + rituximab.
- The LNH 93-5 study compared the ACVBP regimen to the CHOP in patients aged from 61 to 69 years with aggressive lymphoma and at least one adverse prognostic factor according to the International Prognostic Index. Out of 703 patients included in this study, the results have shown the same complete response rate in the two arms, but a significantly better 3-year event free survival and overall survival in the ACVBP arm than in the CHOP arm. However, the benefit seems to be greater in patients <66 years, due to higher toxicity with the ACVBP regimen in elderly patients.
All the above-mentioned results led us to propose a randomized trial comparing ACVBP to ACVBP + rituximab (R-ACVBP) in previously untreated patients with low risk localized diffuse large B-cell lymphoma (age-adjusted IPI = 0), and to extend the upper age limit from 60 to 65 years.
- Conditions
- Diffuse Large Cell Lymphoma
- Being tested
- rituximab
- Keywords
- lymphoma, diffuse large B-cell, rituximab, chemotherapy
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabDrug
375 mg/m2 on D1
| Study group | Role | What they receive |
|---|---|---|
| R-ACVBP | Experimental | addition of rituximab to standard ACVBP chemotherapy Receives: Drug: rituximab |
| ACVBP | No intervention | standard ACVBP chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS)
events defined as death from any cause, relapse for complete responders (CR) and unconfirmed complete responders (CRu), progression during and after treatment and change of therapy.
Measured: 4 years
Secondary outcomes (4)
Response rate at the end of the treatment
Measured: 6 months
Disease-free survival for complete responders
Measured: 4 years
Overall survival
Measured: 4 years
additionnal toxicities with R-ACVBP
number of SAE
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startDec 2003
- Primary completionJul 2008
- Study completionApr 2012
Why it stopped: Low acrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diffuse Large Cell LymphomaStudies 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
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lymphoma Study Association
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Nicolas Ketterer, MD, Principal investigator, Lymphoma Study AssociationFelix Reyes, MD, Study director, Lymphoma Study AssociationHervé Tilly, MD, Study chair, Lymphoma Study AssociationCorinne Haioun, MD, Study chair, Lymphoma Study Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140660
- Sponsor's protocol ID
- LNH03-1B
- Status last verified
- Mar 2017
- First submitted
- 31 Aug 2005
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reyes F, Lepage E, Ganem G, Molina TJ, Brice P, Coiffier B, Morel P, Ferme C, Bosly A, Lederlin P, Laurent G, Tilly H; Groupe d'Etude des Lymphomes de l'Adulte (GELA). ACVBP versus CHOP plus radiotherapy for localized aggressive lymphoma. N Engl J Med. 2005 Mar 24;352(12):1197-205. doi: 10.1056/NEJMoa042040.
PubMed 15788496Miller TP, Dahlberg S, Cassady JR, Adelstein DJ, Spier CM, Grogan TM, LeBlanc M, Carlin S, Chase E, Fisher RI. Chemotherapy alone compared with chemotherapy plus radiotherapy for localized intermediate- and high-grade non-Hodgkin's lymphoma. N Engl J Med. 1998 Jul 2;339(1):21-6. doi: 10.1056/NEJM199807023390104.
PubMed 9647875Feugier P, Van Hoof A, Sebban C, Solal-Celigny P, Bouabdallah R, Ferme C, Christian B, Lepage E, Tilly H, Morschhauser F, Gaulard P, Salles G, Bosly A, Gisselbrecht C, Reyes F, Coiffier B. Long-term results of the R-CHOP study in the treatment of elderly patients with diffuse large B-cell lymphoma: a study by the Groupe d'Etude des Lymphomes de l'Adulte. J Clin Oncol. 2005 Jun 20;23(18):4117-26. doi: 10.1200/JCO.2005.09.131. Epub 2005 May 2.
PubMed 15867204Tilly 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 12920037Copie-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 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of ACVBP Versus ACVBP Plus Rituximab in Previously Untreated Patients Aged From 18 to 65 Years With Low-risk Localized Diffuse Large B-cell Lymphoma (Age-adjusted IPI = 0)
- ClinicalTrials.gov ID
- NCT00140660
- Acronym / sponsor ID
- LNH03-1B
- Conditions
- Diffuse Large Cell Lymphoma
- Keywords
- lymphoma, diffuse large B-cell, rituximab, chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low acrual
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Lymphoma Study AssociationUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Dec 2003 (actual)
- Primary completion
- Jul 2008 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 1 Sep 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.
This study is a multicentric randomized trial evaluating the efficacy of the combination R-ACVBP in patients 18 to 65 years with low risk localized diffuse large B-cell lymphoma.
Detailed description
Approximately 30 to 40% of diffuse large B cell lymphomas are localized at diagnosis (stage I-II). Until the seventies, radiotherapy was used as the single modality to treat these localized stages but no more than half of the patients were cured. From the eighties, anthracycline-based regimens combined or not with radiotherapy gave superior results in term of relapse free survival compared with radiotherapy alone. Later on Miller et al. published a randomized study showing that 3 cycles of CHOP combined with radiotherapy gave superior results in term of overall survival as compared with 8 cycles of CHOP. This study was recently updated with a follow up of more than 8 years and shows no more difference between the two arms, due to an excess of late mortality after the combined treatment.
Recently, two trials were conducted by the GELA to compare chemotherapy alone to a combined chemo-radiotherapy approach in patients with low risk localized diffuse large cell lymphoma (age-adjusted IPI = 0).
- The objective of the LNH 93-1 study was to compare, in patients aged from 18 to 60 years 3 cycles of CHOP followed by radiotherapy with chemotherapy alone consisting in 3 cycles of ACVBP. The ACVBP regimen includes a more intensive induction followed by a sequential consolidation. With a median follow up of 55 months, the results have shown a superiority of the ACVBP arm for both the 5 year event free (83% vs. 74%, p = 0.004) and overall survival (89% vs. 80%, p = 0.02).
- The LNH 93-4 study compared in patients >60 years the association of 4 cycles of CHOP + radiotherapy to the same regimen without irradiation. This study fails to demonstrate any benefit of the combined chemo-radiotherapy in term of survival, but indicates that chemotherapy alone is probably less toxic in patients older than 69 years.
Considering these two trials, we concluded that radiotherapy given after chemotherapy did not give any benefit to elderly patients treated for a low risk localized diffuse large cell lymphoma, and that ACVBP regimen was superior to 3 CHOP + radiotherapy in patients <60 years, and has to be considered as the treatment of reference in these patients.
Two other GELA trials contributed recently to improve the treatment of diffuse large B cell lymphoma and have to be considered for the elaboration of future studies:
- The objective of the LNH 98-5 study was to compare the association of CHOP + rituximab (R-CHOP) to the CHOP regimen alone in elderly patients with previously untreated large B-cell lymphoma. The analysis showed a significant superiority of the association CHOP + rituximab.
- The LNH 93-5 study compared the ACVBP regimen to the CHOP in patients aged from 61 to 69 years with aggressive lymphoma and at least one adverse prognostic factor according to the International Prognostic Index. Out of 703 patients included in this study, the results have shown the same complete response rate in the two arms, but a significantly better 3-year event free survival and overall survival in the ACVBP arm than in the CHOP arm. However, the benefit seems to be greater in patients <66 years, due to higher toxicity with the ACVBP regimen in elderly patients.
All the above-mentioned results led us to propose a randomized trial comparing ACVBP to ACVBP + rituximab (R-ACVBP) in previously untreated patients with low risk localized diffuse large B-cell lymphoma (age-adjusted IPI = 0), and to extend the upper age limit 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: rituximabaddition of rituximab to standard ACVBP chemotherapy |
| ACVBP | No intervention | –standard ACVBP chemotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO classification).
- Age from 18 to 65 years.
- Patient not previously treated.
- Ann Arbor stage I or II.
- ECOG performance status < 2.
Key exclusion criteria (10 listed)
- Any other histological type of lymphoma. vAny 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 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).
- Poor bone marrow reserve as defined by neutrophils < 1.5 G/l or platelets < 100 G/l.
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 on D1 | Drug | R-ACVBP |
Primary outcome
Event-free survival (EFS)
Time frame: 4 years
events defined as death from any cause, relapse for complete responders (CR) and unconfirmed complete responders (CRu), progression during and after treatment and change of therapy.
4 secondary outcomes
Response rate at the end of the treatment
Time frame: 6 months
Disease-free survival for complete responders
Time frame: 4 years
Overall survival
Time frame: 4 years
additionnal toxicities with R-ACVBP
Time frame: 4 years
Results and safety
The study was stopped early (reason given: Low acrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Background: PubMed 15788496Reyes F, Lepage E, Ganem G, Molina TJ, Brice P, Coiffier B, Morel P, Ferme C, Bosly A, Lederlin P, Laurent G, Tilly H; Groupe d'Etude des Lymphomes de l'Adulte (GELA). ACVBP versus CHOP plus radiotherapy for localized aggressive lymphoma. N Engl J Med. 2005 Mar 24;352(12):1197-205. doi: 10.1056/NEJMoa042040.
- Background: PubMed 9647875Miller TP, Dahlberg S, Cassady JR, Adelstein DJ, Spier CM, Grogan TM, LeBlanc M, Carlin S, Chase E, Fisher RI. Chemotherapy alone compared with chemotherapy plus radiotherapy for localized intermediate- and high-grade non-Hodgkin's lymphoma. N Engl J Med. 1998 Jul 2;339(1):21-6. doi: 10.1056/NEJM199807023390104.
- Background: PubMed 15867204Feugier P, Van Hoof A, Sebban C, Solal-Celigny P, Bouabdallah R, Ferme C, Christian B, Lepage E, Tilly H, Morschhauser F, Gaulard P, Salles G, Bosly A, Gisselbrecht C, Reyes F, Coiffier B. Long-term results of the R-CHOP study in the treatment of elderly patients with diffuse large B-cell lymphoma: a study by the Groupe d'Etude des Lymphomes de l'Adulte. J Clin Oncol. 2005 Jun 20;23(18):4117-26. doi: 10.1200/JCO.2005.09.131. Epub 2005 May 2.
- 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.
- 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.
- Individual participant dataSharing planned: No
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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.
Nicolas Ketterer, MD principal investigator
Lymphoma Study Association
Felix Reyes, MD study director
Lymphoma Study Association
Hervé Tilly, MD study chair
Lymphoma Study Association
11 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 in people with Diffuse Large Cell Lymphoma, run by Lymphoma Study Association at 11 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 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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: Low acrual). 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 (EFS) (time frame: 4 years). 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 NCT00140660, which also lists 5 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 13 Mar 2017.