Lymphoma, Large-Cell, DiffuseNCT00561379
Diffuse Large B Cell Lymphoma of the Adult: Randomization Between High Dose Chemotherapy With Rituximab and CHOP 14-Rituximab
A study testing CHOP+RITUXIMAB and CEEP-RITUXIMAB in people with Lymphoma, Large-Cell, Diffuse, run by Nantes University Hospital at 1 site in France.
Trial summary
The aim of the protocol is to compare the outcome of patients with DLBCL stage II bulky, III or IV with 1 to 3 adverse prognostic factors according to the International prognostic index. 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?
- CHOP+RITUXIMAB and CEEP-RITUXIMAB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2005to May 2013
- Phase
- Interventional
- 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
- Age ≥ 18 et ≤ 60 and male and female
- Diffuse large B cell lymphoma according to WHO classification phénotype B CD 20 +
- Stage I et II tumor bulk > 7 cm and stage III et IV Ann Arbor.
- Non previously treated
- HIV négative
- Signed informed consent
Who cannot join
- Age < 18 and/or > 60 ans
- NHL not DLBCL
- Lymphoblastic Lymphoma
- Burkitt's Lymphoma
- Low grade Lymphoma transformed
- Primary CNS Lymphomal
Show all 16Show fewer
- Post- transplantation Lymphoma
- CD20 negative
- Ann Arbor stage I or II without tumor bulk > 7 cm
- Previous treatment
- HIV positive
- Contre-indication to Rituximab use according to SmPC
- Contre-indication to high dose chemotherapy due to organ failure not related to the lymphoma
- Cancer or history of cancer with the exception of in situ cancer of the cervix or non-invasive skin epithelioma
- Patient not able to understand the proposed treatments
- Refusal to sign the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frontline Therapy of Diffuse Large B Cell Lymphoma of the Adult ( 18 to 60 Years Old): Randomization Between High Dose Chemotherapy With Rituximab and CHOP 14 -Rituximab. Multicentric Randomized Prospective Trial.
The aim of the protocol is to compare the outcome of patients with DLBCL stage II bulky, III or IV with 1 to 3 adverse prognostic factors according to the International prognostic index. Patients with eligibility criteria and who gave informed consent will be randomised between CHOP-14- Rituximab x 8 courses and High dose chemotherapy with rituximab including autologous stem cell support. The aim of the study is to compare the Event free survival between the two arms and to gain insight into the prognostic significance of several biological markers gathered at the time of diagnosis/randomisation ( i.e. Fcgamma R III A genotyping, DNA profile and BCL é expression).
Read the detailed description
Diffuse Large B Cell Lymphoma not previously treated
- Conditions
- Lymphoma, Large-Cell, Diffuse
- Being tested
- CHOP+RITUXIMAB, CEEP-RITUXIMAB
- Keywords
- Diffuse Large B Cell Lymphoma, not previously treated
- 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.
CHOP+RITUXIMABDrug
CHOP-14- Rituximab x 8 courses
CEEP-RITUXIMABDrug
High dose chemotherapy with rituximab including autologous stem cell support.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: CHOP+RITUXIMAB |
| 2 | Active comparator | Not described Receives: Drug: CEEP-RITUXIMAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 years Event-free survival ( Kaplan Meier method)
Secondary outcomes (3)
3 years overall survival
Prognostic impact of: Level of expression of protéine bcl2 protein in tumor cells; FCGR3A genotype; génomic profile (DNA microarray)on response, survival, and Event-Free-Survival
Cost
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study startApr 2005
- Primary completionMay 2013
- Study completionMay 2013
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.
- More trials run by Nantes University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Noel Milpied, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561379
- Sponsor's protocol ID
- BRD 04/4-O
- Status last verified
- Jun 2013
- First submitted
- 20 Nov 2007
- Last updated
- 13 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frontline Therapy of Diffuse Large B Cell Lymphoma of the Adult ( 18 to 60 Years Old): Randomization Between High Dose Chemotherapy With Rituximab and CHOP 14 -Rituximab. Multicentric Randomized Prospective Trial.
- ClinicalTrials.gov ID
- NCT00561379
- Acronym / sponsor ID
- BRD 04/4-O
- Conditions
- Lymphoma, Large-Cell, Diffuse
- Keywords
- Diffuse Large B Cell Lymphoma, not previously treated
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 21 Nov 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.
The aim of the protocol is to compare the outcome of patients with DLBCL stage II bulky, III or IV with 1 to 3 adverse prognostic factors according to the International prognostic index. Patients with eligibility criteria and who gave informed consent will be randomised between CHOP-14- Rituximab x 8 courses and High dose chemotherapy with rituximab including autologous stem cell support. The aim of the study is to compare the Event free survival between the two arms and to gain insight into the prognostic significance of several biological markers gathered at the time of diagnosis/randomisation ( i.e. Fcgamma R III A genotyping, DNA profile and BCL é expression).
Detailed description
Diffuse Large B Cell Lymphoma not previously treated
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: CHOP+RITUXIMAB |
| 2 | Active comparator | Drug: CEEP-RITUXIMAB |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age ≥ 18 et ≤ 60 and male and female
- Diffuse large B cell lymphoma according to WHO classification phénotype B CD 20 +
- Stage I et II tumor bulk > 7 cm and stage III et IV Ann Arbor.
- Non previously treated
- HIV négative
Key exclusion criteria (16 listed)
- Age < 18 and/or > 60 ans
- NHL not DLBCL
- Lymphoblastic Lymphoma
- Burkitt's Lymphoma
- Low grade Lymphoma transformed
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 |
|---|---|---|
| CHOP+RITUXIMABCHOP-14- Rituximab x 8 courses | Drug | 1 |
| CEEP-RITUXIMABHigh dose chemotherapy with rituximab including autologous stem cell support. | Drug | 2 |
Primary outcome
3 years Event-free survival ( Kaplan Meier method)
3 secondary outcomes
3 years overall survival
Prognostic impact of: Level of expression of protéine bcl2 protein in tumor cells; FCGR3A genotype; génomic profile (DNA microarray)on response, survival, and Event-Free-Survival
Cost
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 Jun 2013.
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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.
Noel Milpied, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHOP+RITUXIMAB and CEEP-RITUXIMAB in people with Lymphoma, Large-Cell, Diffuse, run by Nantes University Hospital 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 6 inclusion and 16 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 Jun 2013. 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.
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?
3 years Event-free survival ( Kaplan Meier method). 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 Jun 2013.