Hodgkin´s LymphomaPhase 2NCT00284271
Feasibility and Efficacy of BACOPP-21 for Patients > 60 Years With Intermediate or Advanced Hodgkins Lymphoma
A Phase 2 study testing Cyclophosphamide, Adramycin and Procarbacine in people with Hodgkin´s Lymphoma, run by University of Cologne at 1 site in Germany.
Trial summary
This study is designed to test (1) feasibility and efficiancy of new BACOPP regimen and (2) toxicity, overall response and FFTF. Read more about this study
- Who is it for?
- Ages 61 to 75 years
- Conditions the study is for
- Hodgkin´s Lymphoma
- What is being tested?
- Cyclophosphamide, Adramycin and Procarbacine
- How many people
- 65 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2004to Dec 2005
- 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 61 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hodgkin´s lymphoma (histologically proven)
- CS (PS) I and II with one of the risk factors a-d
- bulky mediastinal mass (> 1/3 maximum transverse thorax diameter)
- extranodal involvement
- ESR > 50 (A), > 30 (B-symptoms)
- 3 or more lymph node areas involved
- CS (PS) III and IV
- Written informed consent
Who cannot join
- Leukocytes <3000/microl
- Platelets <100000/microl
- Hodgkin´s Disease as "composite lymphoma"
- Activity index (WHO) < grade 2
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to test (1) feasibility and efficiancy of new BACOPP regimen and (2) toxicity, overall response and FFTF.
- Conditions
- Hodgkin´s Lymphoma
- Being tested
- Cyclophosphamide, Adramycin, Procarbacine, Prednisone, Vincristine
- Keywords
- Hodgkin´s Lymphoma, eldery patients, primary diagnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
AdramycinDrug
ProcarbacineDrug
PrednisoneDrug
VincristineDrug
BleomycinDrug
Erythropoietin betaDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2006 (estimated)
- Study startJan 2004
- Primary completionDec 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´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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Investigators
- Andreas Josting, Dr., Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284271
- Sponsor's protocol ID
- BACOPP-21
- Status last verified
- Jul 2011
- First submitted
- 27 Jan 2006
- Last updated
- 29 Jul 2011
- Results posted
- No
Publications
Halbsguth TV, Nogova L, Mueller H, Sieniawski M, Eichenauer DA, Schober T, Nisters-Backes H, Borchmann P, Diehl V, Engert A, Josting A. Phase 2 study of BACOPP (bleomycin, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone) in older patients with Hodgkin lymphoma: a report from the German Hodgkin Study Group (GHSG). Blood. 2010 Sep 23;116(12):2026-32. doi: 10.1182/blood-2009-11-253211. Epub 2010 Jun 15.
PubMed 20551376
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of BACOPP-21 for Patients > 60 Years With Intermediate or Advanced Hodgkins Lymphoma
- ClinicalTrials.gov ID
- NCT00284271
- Acronym / sponsor ID
- BACOPP-21
- Conditions
- Hodgkin´s Lymphoma
- Keywords
- Hodgkin´s Lymphoma, eldery patients, primary diagnosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Dec 2005 (actual)
- First posted
- 31 Jan 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.
This study is designed to test (1) feasibility and efficiancy of new BACOPP regimen and (2) toxicity, overall response and FFTF.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 61 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Hodgkin´s lymphoma (histologically proven)
- CS (PS) I and II with one of the risk factors a-d
- CS (PS) III and IV
- Written informed 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 | – |
| Adramycin | Drug | – |
| Procarbacine | Drug | – |
| Prednisone | Drug | – |
| Vincristine | Drug | – |
| Bleomycin | Drug | – |
| Erythropoietin beta | 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 29 Jul 2011.
- Results publication: PubMed 20551376Halbsguth TV, Nogova L, Mueller H, Sieniawski M, Eichenauer DA, Schober T, Nisters-Backes H, Borchmann P, Diehl V, Engert A, Josting A. Phase 2 study of BACOPP (bleomycin, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone) in older patients with Hodgkin lymphoma: a report from the German Hodgkin Study Group (GHSG). Blood. 2010 Sep 23;116(12):2026-32. doi: 10.1182/blood-2009-11-253211. Epub 2010 Jun 15.
Related trials for Hodgkin´s Lymphoma
RecruitingPhase 1/2
A Phase I/II Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
B-cell Non-Hodgkin Lymphoma
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
RecruitingPhase 1/2
A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.
Chronic Lymphocytic Leukemia, CLL
Active, not recruitingPhase 1
Autologous/Allogeneic TGFbeta-resistant LMP-specific CTL, Lymphoma (TGF-beta)
Lymphoma, Hodgkin's Disease
RecruitingObservational study
Natural History of KSHV-Associated Multicentric Castleman s Disease
Multicentric Castleman s Disease
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 Josting, Dr. 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 Cyclophosphamide, Adramycin and Procarbacine in people with Hodgkin´s 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 8 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 29 Jul 2011. 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 NCT00284271, 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 29 Jul 2011.