Lymphocyte Predominant Hodgkin´s Lymphoma (LPHD)Phase 2NCT00346684
Rituximab in Primary Lymphocyte Predominant Hodgkin´s Disease(RIPL)
A Phase 2 study testing Rituximab in people with Lymphocyte Predominant Hodgkin´s Lymphoma (LPHD), run by University of Cologne at 1 site in Germany.
Trial summary
First line therapy for patients with Lymphocyte predominant Hodgkin´s Disease (LPHD) in clinical stage IA using the monoclonal anti-CD20 antibody rituximab Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lymphocyte Predominant Hodgkin´s Lymphoma (LPHD)
- What is being tested?
- Rituximab
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Jul 2006to Nov 2007
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lymphocyte predominant Hodgkin´s lymphoma (histologically proven)
- clinical stage IA (without risk factors: large mediastinal mass, extranodal involvement, ESR > 50mm/h)
- age 18 - 75
- WHO performance status 0-3
- normal organ function
- written informed consent
Who cannot join
- classical Hodgkin´s lymphoma
- composite lymphoma
- leucocytes < 3000/µl
- thrombocytes < 100.000/µl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rituximab in Primary LPHD (RIPL) - First Line Therapy for Patients With Lymphocyte Predominant Hodgkin´s Disease (LPHD) in Clinical Stage IA Using the Monoclonal Anti-CD20 Antibody Rituximab.
First line therapy for patients with Lymphocyte predominant Hodgkin´s Disease (LPHD) in clinical stage IA using the monoclonal anti-CD20 antibody rituximab
- Being tested
- Rituximab
- Keywords
- Lymphoma, LPHD, Rituximab
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2006 (estimated)
- Study startJul 2006
- Primary completionNov 2007
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 Lymphocyte Predominant Hodgkin´s Lymphoma (LPHD)Studies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Investigators
- Andreas Engert, Principal investigator, Universitiy of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00346684
- Sponsor's protocol ID
- RIPL
- Status last verified
- Aug 2008
- First submitted
- 29 Jun 2006
- Last updated
- 12 Aug 2008
- Results posted
- No
Publications
Eichenauer DA, Plutschow A, Fuchs M, Hartmann S, Hansmann ML, Boll B, von Tresckow B, Borchmann P, Engert A. Rituximab in newly diagnosed stage IA nodular lymphocyte-predominant Hodgkin lymphoma: long-term follow-up of a phase 2 study from the German Hodgkin Study Group. Leukemia. 2020 Mar;34(3):953-956. doi: 10.1038/s41375-019-0609-3. Epub 2019 Oct 21. No abstract available.
PubMed 31636342Eichenauer DA, Fuchs M, Pluetschow A, Klimm B, Halbsguth T, Boll B, von Tresckow B, Nogova L, Borchmann P, Engert A. Phase 2 study of rituximab in newly diagnosed stage IA nodular lymphocyte-predominant Hodgkin lymphoma: a report from the German Hodgkin Study Group. Blood. 2011 Oct 20;118(16):4363-5. doi: 10.1182/blood-2011-06-361055. Epub 2011 Aug 9.
PubMed 21828141
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rituximab in Primary LPHD (RIPL) - First Line Therapy for Patients With Lymphocyte Predominant Hodgkin´s Disease (LPHD) in Clinical Stage IA Using the Monoclonal Anti-CD20 Antibody Rituximab.
- ClinicalTrials.gov ID
- NCT00346684
- Acronym / sponsor ID
- RIPL
- Keywords
- Lymphoma, LPHD, Rituximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Nov 2007 (actual)
- First posted
- 30 Jun 2006 (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.
First line therapy for patients with Lymphocyte predominant Hodgkin´s Disease (LPHD) in clinical stage IA using the monoclonal anti-CD20 antibody rituximab
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- lymphocyte predominant Hodgkin´s lymphoma (histologically proven)
- clinical stage IA (without risk factors: large mediastinal mass, extranodal involvement, ESR > 50mm/h)
- age 18 - 75
- WHO performance status 0-3
- normal organ function
Key exclusion criteria (4 listed)
- classical Hodgkin´s lymphoma
- composite lymphoma
- leucocytes < 3000/µl
- thrombocytes < 100.000/µl
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 | Drug | – |
Primary outcome
Not reported in the source record.
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 12 Aug 2008.
- Derived from this study: PubMed 31636342Eichenauer DA, Plutschow A, Fuchs M, Hartmann S, Hansmann ML, Boll B, von Tresckow B, Borchmann P, Engert A. Rituximab in newly diagnosed stage IA nodular lymphocyte-predominant Hodgkin lymphoma: long-term follow-up of a phase 2 study from the German Hodgkin Study Group. Leukemia. 2020 Mar;34(3):953-956. doi: 10.1038/s41375-019-0609-3. Epub 2019 Oct 21. No abstract available.
- Derived from this study: PubMed 21828141Eichenauer DA, Fuchs M, Pluetschow A, Klimm B, Halbsguth T, Boll B, von Tresckow B, Nogova L, Borchmann P, Engert A. Phase 2 study of rituximab in newly diagnosed stage IA nodular lymphocyte-predominant Hodgkin lymphoma: a report from the German Hodgkin Study Group. Blood. 2011 Oct 20;118(16):4363-5. doi: 10.1182/blood-2011-06-361055. Epub 2011 Aug 9.
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.
Andreas Engert principal investigator
Universitiy of Cologne
1 site 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 in people with Lymphocyte Predominant Hodgkin´s Lymphoma (LPHD), run by University of Cologne at 1 site 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 6 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 12 Aug 2008. 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00346684, 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 12 Aug 2008.