Hodgkin's DiseasePhase 1/2NCT00147875
Study of Prednisone, Vinblastine, Doxorubicin, and Gemcitabine in Elderly Patients With Advanced Stages Hodgkin's Lymphoma
A Phase 1/2 study testing Prednisone, Vinblastine and Doxorubicin (Adriamycin) in people with Hodgkin's Disease, run by University of Cologne at 1 site in Germany.
Trial summary
The objectives of this study are to assess the feasibility and efficacy of a combination chemotherapy (PVAG) in elderly patients with advanced stages Hodgkin's lymphoma. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Hodgkin's Disease
- What is being tested?
- Prednisone, Vinblastine and Doxorubicin (Adriamycin)
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2004to Jul 2007
- Phase
- Phase 1/2
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hodgkin's lymphoma (histologically proven)
- Clinical stage IIB (with risk factors bulky mediastinal mass and/or extranodal involvement), III, or IV
- No prior antitumor therapy
- Age 60 to 75 years
- WHO performance status 0-2
- Normal pulmonary function
- Written informed consent
Who cannot join
- The following histologies are excluded: lymphocyte predominant HD
- Leukocytes < 2,500/microL
- Platelets < 100,000/microL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PVAG - Phase I/II Dose Finding Trial in Elderly Patients (> 60 Years) With Advanced Stages Hodgkin's Lymphoma
The objectives of this study are to assess the feasibility and efficacy of a combination chemotherapy (PVAG) in elderly patients with advanced stages Hodgkin's lymphoma.
Read the detailed description
Gemcitabine shows promising activity in patients with relapsed lymphoma either administered as single agent or in combination with other cytotoxic agents. No trial to date evaluated its role in patients with primary Hodgkin's lymphoma. We therefore developed a three-weekly regimen based on the standard ABVD regimen.
- Conditions
- Hodgkin's Disease
- Being tested
- Prednisone, Vinblastine, Doxorubicin (Adriamycin), Gemcitabine
- Keywords
- Lymphoma, Gemcitabine, Advanced stages Hodgkin's lymphoma, Elderly
- Medical subject headings
- Hodgkin Disease, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
VinblastineDrug
Doxorubicin (Adriamycin)Drug
GemcitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Dose-limiting toxicities and dose reductions
Phase II: Treatment administration and complete response rate
Secondary outcomes (4)
Toxicities
Supportive care (RBCT need, antibiotic need)
Early progression rate
Overall survival
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 2004
- Primary completionJul 2007
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's 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- German Hodgkin's Lymphoma Study Group, Eli Lilly and Company
- Investigators
- Andreas Engert, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00147875
- Sponsor's protocol ID
- PVAG elderly
- Status last verified
- Sep 2009
- First submitted
- 2 Sep 2005
- Last updated
- 7 Sep 2009
- Results posted
- No
Publications
Boll B, Bredenfeld H, Gorgen H, Halbsguth T, Eich HT, Soekler M, Markova J, Keller U, Graeven U, Kremers S, Geissler M, Trenn G, Fuchs M, von Tresckow B, Eichenauer DA, Borchmann P, Engert A. Phase 2 study of PVAG (prednisone, vinblastine, doxorubicin, gemcitabine) in elderly patients with early unfavorable or advanced stage Hodgkin lymphoma. Blood. 2011 Dec 8;118(24):6292-8. doi: 10.1182/blood-2011-07-368167. Epub 2011 Sep 13.
PubMed 21917759
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PVAG - Phase I/II Dose Finding Trial in Elderly Patients (> 60 Years) With Advanced Stages Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00147875
- Acronym / sponsor ID
- PVAG elderly
- Conditions
- Hodgkin's Disease
- Keywords
- Lymphoma, Gemcitabine, Advanced stages Hodgkin's lymphoma, Elderly
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- German Hodgkin's Lymphoma Study Group, Eli Lilly and Company
- Study start
- Mar 2004
- Primary completion
- Jul 2007 (actual)
- 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 objectives of this study are to assess the feasibility and efficacy of a combination chemotherapy (PVAG) in elderly patients with advanced stages Hodgkin's lymphoma.
Detailed description
Gemcitabine shows promising activity in patients with relapsed lymphoma either administered as single agent or in combination with other cytotoxic agents. No trial to date evaluated its role in patients with primary Hodgkin's lymphoma. We therefore developed a three-weekly regimen based on the standard ABVD regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hodgkin's lymphoma (histologically proven)
- Clinical stage IIB (with risk factors bulky mediastinal mass and/or extranodal involvement), III, or IV
- No prior antitumor therapy
- Age 60 to 75 years
- WHO performance status 0-2
Key exclusion criteria (3 listed)
- The following histologies are excluded: lymphocyte predominant HD
- Leukocytes < 2,500/microL
- Platelets < 100,000/microL
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 |
|---|---|---|
| Prednisone | Drug | – |
| Vinblastine | Drug | – |
| Doxorubicin (Adriamycin) | Drug | – |
| Gemcitabine | Drug | – |
Primary outcome
Phase I: Dose-limiting toxicities and dose reductions
Phase II: Treatment administration and complete response rate
4 secondary outcomes
Toxicities
Supportive care (RBCT need, antibiotic need)
Early progression rate
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 7 Sep 2009.
- Derived from this study: PubMed 21917759Boll B, Bredenfeld H, Gorgen H, Halbsguth T, Eich HT, Soekler M, Markova J, Keller U, Graeven U, Kremers S, Geissler M, Trenn G, Fuchs M, von Tresckow B, Eichenauer DA, Borchmann P, Engert A. Phase 2 study of PVAG (prednisone, vinblastine, doxorubicin, gemcitabine) in elderly patients with early unfavorable or advanced stage Hodgkin lymphoma. Blood. 2011 Dec 8;118(24):6292-8. doi: 10.1182/blood-2011-07-368167. Epub 2011 Sep 13.
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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 1/2 study testing Prednisone, Vinblastine and Doxorubicin (Adriamycin) in people with Hodgkin's 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 7 inclusion and 3 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 7 Sep 2009. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Phase I: Dose-limiting toxicities and dose reductions. 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?
On the ClinicalTrials.gov record for NCT00147875, 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 7 Sep 2009.