Primary Gastric Diffuse-Large B-Cell LymphomaPhase 2NCT00204659
Phase II Study With Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin's Lymphoma
A Phase 2 study testing Rituximab + CHOP chemotherapy in people with Primary Gastric Diffuse-Large B-Cell Lymphoma, run by University Hospital Tuebingen at 5 sites in Germany.
Trial summary
The optimal treatment of primary gastric diffuse large B-cell lymphoma (PG-DLBCL) has not yet been defined. In most circumstances, a stomach-conserving approach is favored, but the role of radiotherapy is still a matter of debate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Gastric Diffuse-Large B-Cell Lymphoma
- What is being tested?
- Rituximab + CHOP chemotherapy
- How many people
- 30 participants
- Where
- 5 sitesGermany
- Study dates
- Mar 2003to Sep 2008
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Histologically confirmed primary gastric CD20+ DLBCL
- Written informed consent
- ECOG 0-2
Who cannot join
- Secondary aggressive Non-Hodgkin's lymphoma involving the gastric area
- HIV positive patients
- Severe organ dysfunction
- Life expectancy of less than 3 months
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Zentralklinikum Augsburg
Augsburg, 86156
University of Giessen
Giessen, 35392
Klinikum Reutlingen
Reutlingen
University of Tubingen
Tübingen, 72076
Schwarzwald-Baar Clinic
Villingen-Schwenningen, 78050
About this study
Official title: Phase II Study With Rituximab and CHOP in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin's Lymphoma
The optimal treatment of primary gastric diffuse large B-cell lymphoma (PG-DLBCL) has not yet been defined. In most circumstances, a stomach-conserving approach is favored, but the role of radiotherapy is still a matter of debate. Recently, Rituximab along with full-dose CHOP chemotherapy has been shown to improve the outcome in elderly patients with nodal DLBCL. However, no data are available with such a therapy in patients with PG-DLBCL. Therefore, in March 2003, we initiated an ongoing, prospective, multicenter phase II study in patients with PG-DLBCL with 6 to 8 cycles of Rituximab (R; 375 mg/m2) plus CHOP-21 in order to evaluate the safety and efficacy of this approach.
Read the detailed description
see above
- Being tested
- Rituximab + CHOP chemotherapy
- Keywords
- Rituximab, CHOP, DLBCL, gastric lymphoma
- Medical subject headings
- Familial primary gastric lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab + CHOP chemotherapyDrug
Also called MabThera
standard Rituximab + CHOP chemo-immunotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate
Measured: at end of chemo-immunotherapy
Progression-free survival
Measured: at 2 and 5 years
Secondary outcomes (2)
Overall survival
Measured: at 2 and 5 years
Toxicity
Measured: after chemo-immunotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 2003
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Gastric Diffuse-Large B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- Wolfram Brugger, M.D., Principal investigator, Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204659
- Sponsor's protocol ID
- 64-03
- Status last verified
- Sep 2008
- First submitted
- 14 Sep 2005
- Last updated
- 20 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study With Rituximab and CHOP in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00204659
- Acronym / sponsor ID
- 64-03
- Keywords
- Rituximab, CHOP, DLBCL, gastric lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Mar 2003
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 20 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 optimal treatment of primary gastric diffuse large B-cell lymphoma (PG-DLBCL) has not yet been defined. In most circumstances, a stomach-conserving approach is favored, but the role of radiotherapy is still a matter of debate. Recently, Rituximab along with full-dose CHOP chemotherapy has been shown to improve the outcome in elderly patients with nodal DLBCL. However, no data are available with such a therapy in patients with PG-DLBCL. Therefore, in March 2003, we initiated an ongoing, prospective, multicenter phase II study in patients with PG-DLBCL with 6 to 8 cycles of Rituximab (R; 375 mg/m2) plus CHOP-21 in order to evaluate the safety and efficacy of this approach.
Detailed description
see above
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Histologically confirmed primary gastric CD20+ DLBCL
- Written informed consent
- ECOG 0-2
Key exclusion criteria (4 listed)
- Secondary aggressive Non-Hodgkin's lymphoma involving the gastric area
- HIV positive patients
- Severe organ dysfunction
- Life expectancy of less than 3 months
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 |
|---|---|---|
| Rituximab + CHOP chemotherapyAlso: MabTherastandard Rituximab + CHOP chemo-immunotherapy | Drug | – |
Primary outcome
Complete remission rate
Time frame: at end of chemo-immunotherapy
Progression-free survival
Time frame: at 2 and 5 years
2 secondary outcomes
Overall survival
Time frame: at 2 and 5 years
Toxicity
Time frame: after chemo-immunotherapy
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 20 Oct 2008.
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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.
Wolfram Brugger, M.D. principal investigator
Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab + CHOP chemotherapy in people with Primary Gastric Diffuse-Large B-Cell Lymphoma, run by University Hospital Tuebingen at 5 sites in Germany.
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 4 inclusion and 4 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 20 Oct 2008. 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 Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Complete remission rate (time frame: at end of chemo-immunotherapy). The study lists 2 primary outcomes in all. 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 20 Oct 2008.