Hodgkin DiseasePhase 2NCT00148018
Study of Bortezomib (Velcade) in Combination With Dexamethasone to Treat Patients With Relapsed Hodgkin's Lymphoma
A Phase 2 study testing Bortezomib and Dexamethasone in people with Hodgkin Disease, run by University of Cologne at 1 site in Germany.
Trial summary
The primary objective of this study is to evaluate wether bortezomib and dexamethasone are active in patients with relapsed Hodgkin's lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Disease
- What is being tested?
- Bortezomib and Dexamethasone
- How many people
- 37 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2005to not given
- 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
- Hodgkin's lymphoma
- Second or higher relapse (first relapse if high-dose chemotherapy not possible)
- Age >/= 18 years
- No major organ dysfunction or intercurrent disorder
- Written informed consent
Who cannot join
- Pregnant or nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Bortezomib in Combination With Dexamethasone in Patients With Relapsed Hodgkin's Lymphoma
The primary objective of this study is to evaluate wether bortezomib and dexamethasone are active in patients with relapsed Hodgkin's lymphoma.
Read the detailed description
The proteasome-inhibitor bortezomib (Velcade) shows promising activity in various human lymphoma cell line. In addition, several studies in heavily pretreated patients with lymphoma showed also promising results.
- Conditions
- Hodgkin Disease
- Being tested
- Bortezomib, Dexamethasone
- Keywords
- Hodgkin disease, Bortezomib, Relapse, Lymphoma
- Medical subject headings
- Hodgkin Disease, Recurrence, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
DexamethasoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (complete and partial responses)
Secondary outcomes (5)
Toxicity
Event free survival
Overall survival
Duration of response
Treatment administration (dose-intensity, total dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hodgkin DiseaseStudies 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)
- Enrolment
- 37 participants
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- German Hodgkin's Lymphoma Study Group, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Investigators
- Andreas Engert, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148018
- Sponsor's protocol ID
- X05132
- Status last verified
- Sep 2006
- First submitted
- 1 Sep 2005
- Last updated
- 10 Jul 2008
- Results posted
- No
Publications
Trelle S, Sezer O, Naumann R, Rummel M, Keller U, Engert A, Borchmann P. Bortezomib in combination with dexamethasone for patients with relapsed Hodgkin's lymphoma: results of a prematurely closed phase II study (NCT00148018). Haematologica. 2007 Apr;92(4):568-9. doi: 10.3324/haematol.10797.
PubMed 17488673
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Bortezomib in Combination With Dexamethasone in Patients With Relapsed Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00148018
- Acronym / sponsor ID
- X05132
- Conditions
- Hodgkin Disease
- Keywords
- Hodgkin disease, Bortezomib, Relapse, Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 37 participants
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- German Hodgkin's Lymphoma Study Group, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Study start
- Mar 2005
- First posted
- 7 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 this study is to evaluate wether bortezomib and dexamethasone are active in patients with relapsed Hodgkin's lymphoma.
Detailed description
The proteasome-inhibitor bortezomib (Velcade) shows promising activity in various human lymphoma cell line. In addition, several studies in heavily pretreated patients with lymphoma showed also promising results.
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 (5 listed)
- Hodgkin's lymphoma
- Second or higher relapse (first relapse if high-dose chemotherapy not possible)
- Age >/= 18 years
- No major organ dysfunction or intercurrent disorder
- Written informed consent
Key exclusion criteria (1 listed)
- Pregnant or nursing
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 |
|---|---|---|
| Bortezomib | Drug | – |
| Dexamethasone | Drug | – |
Primary outcome
Overall response rate (complete and partial responses)
5 secondary outcomes
Toxicity
Event free survival
Overall survival
Duration of response
Treatment administration (dose-intensity, total dose)
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 10 Jul 2008.
- Derived from this study: PubMed 17488673Trelle S, Sezer O, Naumann R, Rummel M, Keller U, Engert A, Borchmann P. Bortezomib in combination with dexamethasone for patients with relapsed Hodgkin's lymphoma: results of a prematurely closed phase II study (NCT00148018). Haematologica. 2007 Apr;92(4):568-9. doi: 10.3324/haematol.10797.
- Description of study in German (Website of the Competence Network Malignant Lymphoma)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.
Andreas Engert principal investigator
University 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 Bortezomib and Dexamethasone in people with Hodgkin Disease, 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 5 inclusion and 1 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 10 Jul 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 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?
Overall response rate (complete and partial responses). 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 NCT00148018, which also lists 1 linked publication.
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 10 Jul 2008.