Lymphoma, Large-Cell, DiffusePhase 2/3NCT00169130
ACVBP Followed by ASCT in Patients With BCL-2 Positive Diffuse Large B-Cell Lymphoma
A Phase 2/3 study testing doxorubicin, cyclophosphamide and Autologous stem cell transplantation in people with Lymphoma, Large-Cell, Diffuse, run by Lymphoma Study Association at 5 sites in 2 countries.
Trial summary
The primary objective of the study is to evaluate the efficacy of ASCT as consolidation in case of bcl-2 overexpression in non previously treated patients aged 60 years or less with low-intermediate risk diffuse large B-cell lymphoma who responded to ACVBP regimen. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lymphoma, Large-Cell, Diffuse
- What is being tested?
- doxorubicin, cyclophosphamide and Autologous stem cell transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Oct 1999to not given
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient with diffuse large B-cell lymphoma according to the WHO classification (anti CD20 labeling)
- Aged 18 to 60 years
- Non previously treated
- With one and only one of the following adverse characteristics: ECOG performance status 2 or more, or Ann Arbor stage III or IV, or elevated LDH level
- Negative HIV, HBV and HCV serologies (except vaccination)
- With a minimum life expectancy of 3 months
- Having previously signed a written informed consent
Who cannot join
- Any history of treated or non-treated indolent lymphoma.
- T-cell lymphoma.
- Central nervous system or meningeal involvement by lymphoma.
- Any Contra-indication to any drug contained in the chemotherapy regimens.
- Poor renal function (creatinin level>150µmol/l), poor hepatic function (total bilirubin level>30mmol/l, transaminases>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
- Serious active disease (according to the investigator's decision).
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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.
- Childbearing woman.
- Patients previously treated with an organ transplantation.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
France4 sites
Hôpital Henri Mondor
Créteil
Hôpital Saint Louis
Paris, 75010
Centre Hospitalier Lyon Sud
Pierre-Bénite
Centre Henri Becquerel
Rouen, 76000
About this study
Official title: Prospective Study of ACVBP Followed by Autologous Stem Cell Transplantation in Case of BCL-2 Overexpression in Non Previously Treated Patients Aged 60 Years or Less With Low-Intermediate Risk Diffuse Large B-Cell Lymphoma
The primary objective of the study is to evaluate the efficacy of ASCT as consolidation in case of bcl-2 overexpression in non previously treated patients aged 60 years or less with low-intermediate risk diffuse large B-cell lymphoma who responded to ACVBP regimen. Our goal is to obtain a 15% increase of event-free survival at 2 years.
- Conditions
- Lymphoma, Large-Cell, Diffuse
- Being tested
- doxorubicin, cyclophosphamide, Autologous stem cell transplantation
- Keywords
- lymphoma, autologous stem cell transplant, chemotherapy, BCL2
- 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.
doxorubicinDrug
cyclophosphamideDrug
Autologous stem cell transplantationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival.
Secondary outcomes (3)
Complete response rate at the end of treatment.
Disease-free survival for complete responders.
Overall survival.
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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Lymphoma Study Association
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation ARC
- Investigators
- Pierre Morel, MD, Principal investigator, Centre Hospitalier Schaffner, Lens FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169130
- Sponsor's protocol ID
- LNH98-B2
- Status last verified
- Jul 2007
- First submitted
- 12 Sep 2005
- Last updated
- 13 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of ACVBP Followed by Autologous Stem Cell Transplantation in Case of BCL-2 Overexpression in Non Previously Treated Patients Aged 60 Years or Less With Low-Intermediate Risk Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00169130
- Acronym / sponsor ID
- LNH98-B2
- Conditions
- Lymphoma, Large-Cell, Diffuse
- Keywords
- lymphoma, autologous stem cell transplant, chemotherapy, BCL2
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Lymphoma Study AssociationUniversity, hospital or other
- Collaborators
- Fondation ARC
- Study start
- Oct 1999
- 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.
The primary objective of the study is to evaluate the efficacy of ASCT as consolidation in case of bcl-2 overexpression in non previously treated patients aged 60 years or less with low-intermediate risk diffuse large B-cell lymphoma who responded to ACVBP regimen. Our goal is to obtain a 15% increase of event-free survival at 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patient with diffuse large B-cell lymphoma according to the WHO classification (anti CD20 labeling)
- Aged 18 to 60 years
- Non previously treated
- With one and only one of the following adverse characteristics: ECOG performance status 2 or more, or Ann Arbor stage III or IV, or elevated LDH level
- Negative HIV, HBV and HCV serologies (except vaccination)
Key exclusion criteria (11 listed)
- Any history of treated or non-treated indolent lymphoma.
- T-cell lymphoma.
- Central nervous system or meningeal involvement by lymphoma.
- Any Contra-indication to any drug contained in the chemotherapy regimens.
- Poor renal function (creatinin level>150µmol/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 |
|---|---|---|
| doxorubicin | Drug | – |
| cyclophosphamide | Drug | – |
| Autologous stem cell transplantation | Procedure or surgery | – |
Primary outcome
Event free survival.
3 secondary outcomes
Complete response rate at the end of treatment.
Disease-free survival for complete responders.
Overall survival.
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 13 Jul 2007.
- 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.
Pierre Morel, MD principal investigator
Centre Hospitalier Schaffner, Lens FRANCE
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing doxorubicin, cyclophosphamide and Autologous stem cell transplantation in people with Lymphoma, Large-Cell, Diffuse, run by Lymphoma Study Association at 5 sites in 2 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 7 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: finished, as of the sponsor's last update on 13 Jul 2007. 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, Belgium. 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 combined 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.
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 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?
Event free survival.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2007.