Hodgkin LymphomaPhase 2NCT01569204
Targeted BEACOPP Variants in Patients With Newly Diagnosed Advanced Classical Hodgkin Lymphoma
A Phase 2 study testing Etoposide, Cyclophosphamide and Doxorubicin in people with Hodgkin Lymphoma, run by University of Cologne at 1 site in Germany.
Trial summary
The Purpose of this trial is: to determine complete response rate (CRR) after six cycles of chemotherapy to determine complete remission rate (CR/CRr) as final treatment outcome after completion of treatment 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?
- Etoposide, Cyclophosphamide and Doxorubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to Dec 2017
- 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 proven classical Hodgkin lymphoma
- First diagnosis, no previous treatment, age: 18-60 years
- Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV disease
Who cannot join
- Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
- Previous malignancy
- Prior chemotherapy or radiation
Trial locations and contacts
1 site in 1 country.
About this study
The Purpose of this trial is:
- to determine complete response rate (CRR) after six cycles of chemotherapy
- to determine complete remission rate (CR/CRr) as final treatment outcome after completion of treatment
- Conditions
- Hodgkin Lymphoma
- Being tested
- Etoposide, Cyclophosphamide, Doxorubicin, Prednisone, Procarbazine
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtoposideDrug
CyclophosphamideDrug
DoxorubicinDrug
PrednisoneDrug
ProcarbazineDrug
DexamethasoneDrug
DacarbazineDrug
Brentuximab VedotinDrug
| Study group | Role | What they receive |
|---|---|---|
| BrECAPP | Active comparator | modified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin Receives: Drug: Etoposide; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone; Drug: Procarbazine; Drug: Brentuximab Vedotin |
| BrECADD | Active comparator | modified BEACOPP by omitting Bleomycin, Procarbazine and Prednisone and adding Brentuximab Vedotin, Dacarbazine and Dexamethasone Receives: Drug: Etoposide; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Dexamethasone; Drug: Dacarbazine; Drug: Brentuximab Vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate (RR) after six cycles of chemotherapy
Measured: 18 weeks
Complete remission rate (CR/CRr) as final treatment outcome after completion of treatment
Measured: 18 weeks
Secondary outcomes (5)
Progression Free Survival (PFS)
Measured: 2 years
Overall survival (OS)
Measured: 2 years
Adverse event rate
Measured: 2 years
Dose reduction rate
Measured: 18 weeks
Relative dose intensity
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2014
- Study completionDec 2017
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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Peter Borchmann, University of Cologne
- Investigators
- Peter Borchmann, Prof., Principal investigator, University of Cologne, German Hodgkin Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569204
- Sponsor's protocol ID
- Targeted BEACOPP
- Status last verified
- Oct 2018
- First submitted
- 2 Apr 2012
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted BEACOPP Variants in Patients With Newly Diagnosed Advanced Classical Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT01569204
- Acronym / sponsor ID
- Targeted BEACOPP
- Conditions
- Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 Apr 2012 (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 Purpose of this trial is:
- to determine complete response rate (CRR) after six cycles of chemotherapy
- to determine complete remission rate (CR/CRr) as final treatment outcome after completion of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BrECAPP | Active comparator | Drug: Etoposide, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Prednisone, Drug: Procarbazine, Drug: Brentuximab Vedotinmodified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin |
| BrECADD | Active comparator | Drug: Etoposide, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Dexamethasone, Drug: Dacarbazine, Drug: Brentuximab Vedotinmodified BEACOPP by omitting Bleomycin, Procarbazine and Prednisone and adding Brentuximab Vedotin, Dacarbazine and Dexamethasone |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Histologically proven classical Hodgkin lymphoma
- First diagnosis, no previous treatment, age: 18-60 years
- Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV disease
Key exclusion criteria (3 listed)
- Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
- Previous malignancy
- Prior chemotherapy or radiation
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 |
|---|---|---|
| Etoposide | Drug | BrECADD, BrECAPP |
| Cyclophosphamide | Drug | BrECADD, BrECAPP |
| Doxorubicin | Drug | BrECADD, BrECAPP |
| Prednisone | Drug | BrECAPP |
| Procarbazine | Drug | BrECAPP |
| Dexamethasone | Drug | BrECADD |
| Dacarbazine | Drug | BrECADD |
| Brentuximab Vedotin | Drug | BrECADD, BrECAPP |
Primary outcome
Response rate (RR) after six cycles of chemotherapy
Time frame: 18 weeks
Complete remission rate (CR/CRr) as final treatment outcome after completion of treatment
Time frame: 18 weeks
5 secondary outcomes
Progression Free Survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Adverse event rate
Time frame: 2 years
Dose reduction rate
Time frame: 18 weeks
Relative dose intensity
Time frame: 18 weeks
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 Oct 2018.
- Homepage GHSGLink provided by the sponsor.
Related trials for Hodgkin Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
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.
Peter Borchmann, Prof. principal investigator
University of Cologne, German Hodgkin Study Group
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 Etoposide, Cyclophosphamide 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 3 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 29 Oct 2018. 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.
What does the primary outcome measure?
Response rate (RR) after six cycles of chemotherapy (time frame: 18 weeks). 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?
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 Oct 2018.