CD20-Positive Large B-Cell LymphomaPhase 3NCT00169169
Efficacy Study of Rituximab After ASCT in High-Risk Diffuse Large B-Cell Lymphoma
A Phase 3 study testing ACVBP, ACE and rituximab in people with CD20-Positive Large B-Cell Lymphoma, run by Lymphoma Study Association at 5 sites in France.
Trial summary
Rituximab vs observation after high-dose consolidative first-line chemotherapy (HDC) with autologous stem cell transplantation in poor risk diffuse large B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- CD20-Positive Large B-Cell Lymphoma
- What is being tested?
- ACVBP, ACE and rituximab
- Type of treatment
- Surgery or procedure
- How many people
- 430 participants
- Where
- 5 sitesFrance
- Study dates
- Oct 1999to Aug 2005
- 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 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).
- Aged from 18 to 59 years, eligible for transplant.
- Patient not previously treated.
- Age adjusted International Prognostic Index equal to 2 or 3.
- Having previously signed a written informed consent.
- Women of childbearing potential currently practicing an adequate method of contraception.
Who cannot join
- Any other histological type of lymphoma.
- Any history of treated or non-treated indolent lymphoma.
- Central nervous system or meningeal involvement by lymphoma.
- Contra-indication to any drug contained in the chemotherapy regimens.
- Poor renal function (creatinin level>150mmol/l), poor hepatic function (total bilirubin level>30mmol/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).
- HIV, HTLV1 or HBV related disease.
- Any organ transplantation before inclusion.
- Pregnant women.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Hôpital Henri Mondor
Créteil
Hôpital Saint Louis
Paris
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite
Centre Henri Becquerel
Rouen
CHRU de Nancy Brabois
Vandœuvre-lès-Nancy
About this study
Official title: Randomised Phase 3 Study of Rituximab in High-Risk Patients With Diffuse Large B-Cell Lymphoma Who Received a First-Line Consolidative Chemotherapy With Autologous Stem Cell Transplant (ASCT).
Rituximab vs observation after high-dose consolidative first-line chemotherapy (HDC) with autologous stem cell transplantation in poor risk diffuse large B-cell lymphoma.
Read the detailed description
This is a multicentric, open-label, randomized clinical study, evaluating the efficacy and the safety of Rituximab After ASCT in patients aged 18 to 59 years with previously untreated High-Risk (aa-IPI 2 or 3 ) Diffuse Large B-Cell Lymphoma .
The duration of the treatment period is approximately 25 weeks and patients are followed until Death.
From 10/99 to 05/03, 476 patients were enrolled. 235 patients were assigned to receive ACE and 241 to ACVBP. Among the 331 patients, in Complete response (CR+CRu) after induction, who received HDC, 269 were randomized (R2) after hematological recovery to receive either rituximab (n=139) or nothing (n=130).
The final analysis was performed in June 2005.
- Conditions
- CD20-Positive Large B-Cell Lymphoma
- Being tested
- ACVBP, ACE, rituximab, Autologous stem cell transplant
- Keywords
- Diffuse large B cell lymphoma, Rituximab, Autotransplant
- 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.
ACVBPDrug
ACEDrug
rituximabDrug
Autologous stem cell transplantProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
- To compare event-free survival of patients randomized to receive Rituximab or no further therapy after HDT
Secondary outcomes (4)
- To compare response rate to induction treatments (ACVBP vs AC/ACE).
- To evaluate response rate at the end of treatment.
- To compare overall survival (ACVBP vs AC/ACE; Rituximab / nothing)
- To evaluate the safety and tolerability of Rituximab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startOct 1999
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CD20-Positive Large B-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
- 430 participants
Sponsor and investigators
- Lead sponsor
- Lymphoma Study Association
- Sponsor type
- University, hospital or other
- Investigators
- Corinne Haioun, Study chair, Hôpital Henri Mondor, Créteil, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169169
- Sponsor's protocol ID
- LNH-98.3
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Publications
Haioun C, Lepage E, Gisselbrecht C, Salles G, Coiffier B, Brice P, Bosly A, Morel P, Nouvel C, Tilly H, Lederlin P, Sebban C, Briere J, Gaulard P, Reyes F. Survival benefit of high-dose therapy in poor-risk aggressive non-Hodgkin's lymphoma: final analysis of the prospective LNH87-2 protocol--a groupe d'Etude des lymphomes de l'Adulte study. J Clin Oncol. 2000 Aug;18(16):3025-30. doi: 10.1200/JCO.2000.18.16.3025.
PubMed 10944137Coiffier B, Haioun C, Ketterer N, Engert A, Tilly H, Ma D, Johnson P, Lister A, Feuring-Buske M, Radford JA, Capdeville R, Diehl V, Reyes F. Rituximab (anti-CD20 monoclonal antibody) for the treatment of patients with relapsing or refractory aggressive lymphoma: a multicenter phase II study. Blood. 1998 Sep 15;92(6):1927-32.
PubMed 9731049
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Phase 3 Study of Rituximab in High-Risk Patients With Diffuse Large B-Cell Lymphoma Who Received a First-Line Consolidative Chemotherapy With Autologous Stem Cell Transplant (ASCT).
- ClinicalTrials.gov ID
- NCT00169169
- Acronym / sponsor ID
- LNH-98.3
- Conditions
- CD20-Positive Large B-Cell Lymphoma
- Keywords
- Diffuse large B cell lymphoma, Rituximab, Autotransplant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 430 participants
- Lead sponsor
- Lymphoma Study AssociationUniversity, hospital or other
- Study start
- Oct 1999
- Study completion
- Aug 2005
- First posted
- 15 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.
Rituximab vs observation after high-dose consolidative first-line chemotherapy (HDC) with autologous stem cell transplantation in poor risk diffuse large B-cell lymphoma.
Detailed description
This is a multicentric, open-label, randomized clinical study, evaluating the efficacy and the safety of Rituximab After ASCT in patients aged 18 to 59 years with previously untreated High-Risk (aa-IPI 2 or 3 ) Diffuse Large B-Cell Lymphoma .
The duration of the treatment period is approximately 25 weeks and patients are followed until Death.
From 10/99 to 05/03, 476 patients were enrolled. 235 patients were assigned to receive ACE and 241 to ACVBP. Among the 331 patients, in Complete response (CR+CRu) after induction, who received HDC, 269 were randomized (R2) after hematological recovery to receive either rituximab (n=139) or nothing (n=130).
The final analysis was performed in June 2005.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient with histologically proven CD20+ diffuse large B cell lymphoma (WHO Classification).
- Aged from 18 to 59 years, eligible for transplant.
- Patient not previously treated.
- Age adjusted International Prognostic Index equal to 2 or 3.
- Having previously signed a written informed consent.
Key exclusion criteria (11 listed)
- Any other histological type of lymphoma.
- Any history of treated or non-treated indolent lymphoma.
- Central nervous system or meningeal involvement by lymphoma.
- Contra-indication to any drug contained in the chemotherapy regimens.
- Poor renal function (creatinin level>150mmol/l), poor hepatic function (total bilirubin level>30mmol/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 |
|---|---|---|
| ACVBP | Drug | – |
| ACE | Drug | – |
| rituximab | Drug | – |
| Autologous stem cell transplant | Procedure or surgery | – |
Primary outcome
- To compare event-free survival of patients randomized to receive Rituximab or no further therapy after HDT
4 secondary outcomes
- To compare response rate to induction treatments (ACVBP vs AC/ACE).
- To evaluate response rate at the end of treatment.
- To compare overall survival (ACVBP vs AC/ACE; Rituximab / nothing)
- To evaluate the safety and tolerability of Rituximab
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2005.
- Background: PubMed 10944137Haioun C, Lepage E, Gisselbrecht C, Salles G, Coiffier B, Brice P, Bosly A, Morel P, Nouvel C, Tilly H, Lederlin P, Sebban C, Briere J, Gaulard P, Reyes F. Survival benefit of high-dose therapy in poor-risk aggressive non-Hodgkin's lymphoma: final analysis of the prospective LNH87-2 protocol--a groupe d'Etude des lymphomes de l'Adulte study. J Clin Oncol. 2000 Aug;18(16):3025-30. doi: 10.1200/JCO.2000.18.16.3025.
- Background: PubMed 9731049Coiffier B, Haioun C, Ketterer N, Engert A, Tilly H, Ma D, Johnson P, Lister A, Feuring-Buske M, Radford JA, Capdeville R, Diehl V, Reyes F. Rituximab (anti-CD20 monoclonal antibody) for the treatment of patients with relapsing or refractory aggressive lymphoma: a multicenter phase II study. Blood. 1998 Sep 15;92(6):1927-32.
- Official site of the Groupe d'Etude 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.
Corinne Haioun study chair
Hôpital Henri Mondor, Créteil, France
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ACVBP, ACE and rituximab in people with CD20-Positive Large B-Cell Lymphoma, run by Lymphoma Study Association at 5 sites 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 6 inclusion and 11 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 15 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 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. 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?
- To compare event-free survival of patients randomized to receive Rituximab or no further therapy after HDT. 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 NCT00169169, which also lists 2 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 15 Sep 2005.