Hodgkin LymphomaPhase 2NCT00512980
PVAG-14 Pilot for Intermediate Stages Hodgkin Lymphoma
A Phase 2 study testing prednisone, vinblastine and doxorubicin in people with Hodgkin Lymphoma, run by University of Cologne at 1 site in Germany.
Trial summary
A randomized phase II study of prednisone, vinblastine, doxorubicin, and gemcitabine in patients with intermediate stage Hodgkin's lymphoma Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- prednisone, vinblastine and doxorubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Aug 2008to Nov 2013
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Histologically confirmed diagnosis of Hodgkin's lymphoma
- Stage
- Clinical Stage IA, IB, IIA with at least one of the risk factors a-d given below
- Clinical Stage IIB with one or both risk factors c-d given below risk factors:
- Large mediastinal mass (≥ 1/3 of the greatest thorax diameter as measured by chest x-ray)
- Extranodal involvement
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- High erythrocyte sedimentation rate (≥ 50 mm/h in patients without B-symptoms, ≥ 30 mm/h in patients with B-symptoms)
- Three or more involved lymph node areas
- No prior therapy for Hodgkin's lymphoma (exception: pre-phase treatment with corticosteroids and vinca-alkaloids for a maximum of seven days may not preclude trial participation if clinically indicated and all staging examinations have been performed; all forms of prior radiotherapy preclude trial participation)
- Age: 18-60 years
- Signed informed consent with understanding of the study procedures and the investigational nature of the study
- Patient agrees that personal data and tissue samples are provided to the GHSG (protection of privacy as defined by law will be ensured)
- Life expectancy > 3 months according to investigator judgement.
Who cannot join
- Incomplete diagnosis of stage of disease
- Prior or concurrent disease which prevents treatment according to protocol In particular the following contraindications:
- Chronic obstructive pulmonary disease with global insufficiency
- Symptomatic coronary heart disease
- Cardiomyopathy or cardiac insufficiency (NYHA value of EF < 50% or FS < 25%)
- Serious uncontrolled hypertension
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- Uncontrollable infection
- Leucocyte concentration < 3.000/mm3 or thrombocyte concentration < 100.000/mm3
- Creatinin clearance < 60 ml/min
- Bilirubin > 2 mg/dl or GPT > 100 U/l or GOT > 100 U/I (exception: elevated values of Hodgkin's disease liver involvement)
- HIV-Infection according to HIV test
- Chronic or acute Hepatitis
- HD as composite lymphoma
- Prior chemotherapy or radiation
- Malignant disease within the last 5 years (exceptions: basalioma, carcinoma in situ of the cervix uteri, completely resected melanoma TNMpT1)
- Pregnancy, lactation, positive pregnancy test
- Refusal to use effective contraception
- WHO performance index > 2
- Long-term ingestion of corticosteroids (e.g. for chronic polyarthritis) or antineoplastic drugs (e.g. methotrexate)
- Patient's lack of accountability, inability to appreciate the nature, meaning and consequences of the trial and to formulate his/her own wishes correspondingly
- Non compliance: Refusal of blood products during treatment, epilepsy, drug dependency, change of residence abroad, prior cerebral injury or similar circumstances which appear to make protocol treatment or long-term follow-up impossible
- Antiepileptic treatment
- General intolerance of any protocol medication
- Any contraindication for study medication according to the summaries of product information
- Simultaneous participation in another clinical
- Institutionalization by law
- Relation of dependence with the sponsor's representative / trialist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase II Study of Prednisone, Vinblastine, Doxorubicin, and Gemcitabine in Patients With Intermediate Stage Hodgkin's Lymphoma
A randomized phase II study of prednisone, vinblastine, doxorubicin, and gemcitabine in patients with intermediate stage Hodgkin's lymphoma
- Conditions
- Hodgkin Lymphoma
- Being tested
- prednisone, vinblastine, doxorubicin, gemcitabine
- Keywords
- intermediate stages
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisoneDrug
vinblastineDrug
doxorubicinDrug
gemcitabineDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: prednisone; Drug: vinblastine; Drug: doxorubicin; Drug: gemcitabine |
| 2 | Active comparator | Not described Receives: Drug: prednisone; Drug: vinblastine; Drug: doxorubicin; Drug: gemcitabine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study startAug 2008
- Primary completionNov 2013
Why it stopped: lower recruitment rates as expected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Andreas Engert, University of Cologne
- Investigators
- Andreas Engert, Prof, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512980
- Sponsor's protocol ID
- PVAG-14 pilot
- Status last verified
- Dec 2015
- First submitted
- 7 Aug 2007
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Prednisone, Vinblastine, Doxorubicin, and Gemcitabine in Patients With Intermediate Stage Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00512980
- Acronym / sponsor ID
- PVAG-14 pilot
- Conditions
- Hodgkin Lymphoma
- Keywords
- intermediate stages
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lower recruitment rates as expected
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Nov 2013 (actual)
- First posted
- 8 Aug 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.
A randomized phase II study of prednisone, vinblastine, doxorubicin, and gemcitabine in patients with intermediate stage Hodgkin's lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: prednisone, Drug: vinblastine, Drug: doxorubicin, Drug: gemcitabine |
| 2 | Active comparator | Drug: prednisone, Drug: vinblastine, Drug: doxorubicin, Drug: gemcitabine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Histologically confirmed diagnosis of Hodgkin's lymphoma
- Stage
- No prior therapy for Hodgkin's lymphoma (exception: pre-phase treatment with corticosteroids and vinca-alkaloids for a maximum of seven days may not preclude trial participation if clinically indicated and all staging examinations have been performed; all forms of prior radiotherapy preclude trial participation)
- Age: 18-60 years
- Signed informed consent with understanding of the study procedures and the investigational nature of the study
Key exclusion criteria (27 listed)
- Incomplete diagnosis of stage of disease
- Prior or concurrent disease which prevents treatment according to protocol In particular the following contraindications:
- HD as composite lymphoma
- Prior chemotherapy or radiation
- Malignant disease within the last 5 years (exceptions: basalioma, carcinoma in situ of the cervix uteri, completely resected melanoma TNMpT1)
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 | 1, 2 |
| vinblastine | Drug | 1, 2 |
| doxorubicin | Drug | 1, 2 |
| gemcitabine | Drug | 1, 2 |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: lower recruitment rates as expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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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, Prof 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 prednisone, vinblastine and doxorubicin in people with Hodgkin Lymphoma, 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 13 inclusion and 27 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 3 Dec 2015. 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 (reason given: lower recruitment rates as expected). 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.
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 3 Dec 2015.