Hodgkin´s LymphomaPhase 3NCT00265031
HD12 for Advanced Stages
A Phase 3 study testing Cyclophosphamide, Adriamycin and Etoposide in people with Hodgkin´s Lymphoma, run by University of Cologne.
Trial summary
This study is designed to test (1) whether the BEACOPP dosage can be reduced to baseline in the last 4 cycles without loss of effectiveness, and (2) whether consolidating irradiation is necessary following effective chemotherapy. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Hodgkin´s Lymphoma
- What is being tested?
- Cyclophosphamide, Adriamycin and Etoposide
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 1999to not given
- Phase
- Phase 3
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hodgkin´s lymphoma (histologically proven)
- CS(PS) IIB with one or both of the risk factors:
- bulky mediastinal mass (> 1/3 of maximum transverse thorax diameter)
- extranodal involvement
- CS(PS) III, IV
- written informaed consent
Who cannot join
- Leukocytes <3000/microl
- Platelets <100000/microl
- Hodgkin´s Disease as "composite lymphoma"
- Activity index (WHO) < grade 2
About this study
This study is designed to test (1) whether the BEACOPP dosage can be reduced to baseline in the last 4 cycles without loss of effectiveness, and (2) whether consolidating irradiation is necessary following effective chemotherapy.
- Conditions
- Hodgkin´s Lymphoma
- Being tested
- Cyclophosphamide, Adriamycin, Etoposide, Procarbazine, Prednisone
- Keywords
- Hodgkin´s Lymphoma, advanced stages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
AdriamycinDrug
EtoposideDrug
ProcarbazineDrug
PrednisoneDrug
VincristineDrug
BleomycinDrug
radiation therapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2005 (estimated)
- Study startJan 1999
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 Hodgkin´s 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Investigators
- Volker Diehl, Prof., Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265031
- Sponsor's protocol ID
- HD12
- Status last verified
- Aug 2007
- First submitted
- 12 Dec 2005
- Last updated
- 25 Jun 2012
- Results posted
- No
Publications
Borchmann P, Haverkamp H, Diehl V, Cerny T, Markova J, Ho AD, Eich HT, Mueller-Hermelink HK, Kanz L, Greil R, Rank A, Paulus U, Smardova L, Huber C, Dorken B, Nerl C, Krause SW, Mueller RP, Fuchs M, Engert A. Eight cycles of escalated-dose BEACOPP compared with four cycles of escalated-dose BEACOPP followed by four cycles of baseline-dose BEACOPP with or without radiotherapy in patients with advanced-stage hodgkin's lymphoma: final analysis of the HD12 trial of the German Hodgkin Study Group. J Clin Oncol. 2011 Nov 10;29(32):4234-42. doi: 10.1200/JCO.2010.33.9549. Epub 2011 Oct 11.
PubMed 21990399von Tresckow B, Kreissl S, Goergen H, Brockelmann PJ, Pabst T, Fridrik M, Rummel M, Jung W, Thiemer J, Sasse S, Burkle C, Baues C, Diehl V, Engert A, Borchmann P; German Hodgkin Study Group. Intensive treatment strategies in advanced-stage Hodgkin's lymphoma (HD9 and HD12): analysis of long-term survival in two randomised trials. Lancet Haematol. 2018 Oct;5(10):e462-e473. doi: 10.1016/S2352-3026(18)30140-6.
PubMed 30290903
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HD12 for Advanced Stages
- ClinicalTrials.gov ID
- NCT00265031
- Acronym / sponsor ID
- HD12
- Conditions
- Hodgkin´s Lymphoma
- Keywords
- Hodgkin´s Lymphoma, advanced stages
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Jan 1999
- First posted
- 13 Dec 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.
This study is designed to test (1) whether the BEACOPP dosage can be reduced to baseline in the last 4 cycles without loss of effectiveness, and (2) whether consolidating irradiation is necessary following effective chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Hodgkin´s lymphoma (histologically proven)
- CS(PS) IIB with one or both of the risk factors:
- CS(PS) III, IV
- written informaed consent
Key exclusion criteria (4 listed)
- Leukocytes <3000/microl
- Platelets <100000/microl
- Hodgkin´s Disease as "composite lymphoma"
- Activity index (WHO) < grade 2
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 |
|---|---|---|
| Cyclophosphamide | Drug | – |
| Adriamycin | Drug | – |
| Etoposide | Drug | – |
| Procarbazine | Drug | – |
| Prednisone | Drug | – |
| Vincristine | Drug | – |
| Bleomycin | Drug | – |
| radiation therapy | Procedure or surgery | – |
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 25 Jun 2012.
- Results publication: PubMed 21990399Borchmann P, Haverkamp H, Diehl V, Cerny T, Markova J, Ho AD, Eich HT, Mueller-Hermelink HK, Kanz L, Greil R, Rank A, Paulus U, Smardova L, Huber C, Dorken B, Nerl C, Krause SW, Mueller RP, Fuchs M, Engert A. Eight cycles of escalated-dose BEACOPP compared with four cycles of escalated-dose BEACOPP followed by four cycles of baseline-dose BEACOPP with or without radiotherapy in patients with advanced-stage hodgkin's lymphoma: final analysis of the HD12 trial of the German Hodgkin Study Group. J Clin Oncol. 2011 Nov 10;29(32):4234-42. doi: 10.1200/JCO.2010.33.9549. Epub 2011 Oct 11.
- Derived from this study: PubMed 30290903von Tresckow B, Kreissl S, Goergen H, Brockelmann PJ, Pabst T, Fridrik M, Rummel M, Jung W, Thiemer J, Sasse S, Burkle C, Baues C, Diehl V, Engert A, Borchmann P; German Hodgkin Study Group. Intensive treatment strategies in advanced-stage Hodgkin's lymphoma (HD9 and HD12): analysis of long-term survival in two randomised trials. Lancet Haematol. 2018 Oct;5(10):e462-e473. doi: 10.1016/S2352-3026(18)30140-6.
- Description of study i 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.
Volker Diehl, Prof. principal investigator
University of Cologne
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cyclophosphamide, Adriamycin and Etoposide in people with Hodgkin´s Lymphoma, run by University of Cologne.
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 25 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 NCT00265031, 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 25 Jun 2012.