Hodgkin LymphomaPhase 2BVBNCT02191930
Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma
A Phase 2 study testing B-CAP and Brentuximab Vedotin 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 1. Objective response rate (ORR), defined as the proportion of patients having CR, CRr or PR in the centrally reviewed restaging after six cycles of chemotherapy 2. Progression-free survival (PFS) 3 years after registration Read more about this study
- Who is it for?
- Ages 60 to 99 years
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- B-CAP and Brentuximab Vedotin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2015to 16 Mar 2022
- 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 60 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- classical Hodgkin Lymphoma
- Age 60 years or older
- ECOG performance status ≤ 2 or ≤ 3 if due to HL
- CIRS-G score of ≤ 6 and ≤ 3 per organ system (except score 4 for eye, ear, nose and throat)
- Advanced stages: Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV disease
- written informed consent
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- classical Hodgkin Lymphoma
- Age 60 years or older
- stage IA to IVB
- CIRS-G score of ≥ 7 or 4 in one organ system (except score 4 for eye, ear, nose and throat)
- Patients not eligible to curative poly-chemotherapy at the investigators judgment
- written informed consent
Who cannot join
- Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
- Prior chemotherapy or radiation for HL except prephase
- Peripheral neuropathy greater than CTC Grade 1
- Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
- Prior chemotherapy or radiation for HL except prephase as outlined in the protocol
- Peripheral neuropathy greater than CTC Grade 1
Trial locations and contacts
1 site in 1 country.
Germany1 site
1st Dept. of Medicine, Cologne University Hospital
Cologne, 50924
About this study
Official title: Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma - a GHSG-NLG Intergroup Phase II Trial -
The purpose of this trial is to determine
- Objective response rate (ORR), defined as the proportion of patients having CR, CRr or PR in the centrally reviewed restaging after six cycles of chemotherapy
- Progression-free survival (PFS) 3 years after registration
- Conditions
- Hodgkin Lymphoma
- Being tested
- B-CAP, Brentuximab Vedotin
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-CAPDrug
Also called Brentuximab Vedotin, Cyclophosphamide, Doxorubicine, Predniso(lo)ne
Brentuximab VedotinDrug
| Study group | Role | What they receive |
|---|---|---|
| B-CAP | Experimental | Patients with ECOG of 2 or less (3 or less if caused by HL) and CIRS-G score of 6 or less (overall) and 3 or less per organ system receive 6 cycles of B-CAP (Brentuximab vedotin, cyclophosphamide, doxorubicine, predniso(lo)ne). Cycle length is 21 days Receives: Drug: B-CAP |
| Brentoximab Vedotin only | Experimental | Patients with CIRS-G score of 7 ore more receive Brentuximab Vedotin as single agent therapy for up to 16 cycles. Cycle length is 21 days Receives: Drug: Brentuximab Vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Measured: after 6 cycles of therapy (at least 18 weeks after start of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startSep 2015
- Primary completion16 Mar 2022
- Study completion16 Mar 2022
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
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 Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191930
- Sponsor's protocol ID
- Uni-Koeln-1707
- Acronym
- BVB
- Status last verified
- Aug 2024
- First submitted
- 11 Jul 2014
- Last updated
- 23 Aug 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma - a GHSG-NLG Intergroup Phase II Trial -
- ClinicalTrials.gov ID
- NCT02191930
- Acronym / sponsor ID
- BVB / Uni-Koeln-1707
- Conditions
- Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 16 Jul 2014 (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
- Objective response rate (ORR), defined as the proportion of patients having CR, CRr or PR in the centrally reviewed restaging after six cycles of chemotherapy
- Progression-free survival (PFS) 3 years after registration
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B-CAP | Experimental | Drug: B-CAPPatients with ECOG of 2 or less (3 or less if caused by HL) and CIRS-G score of 6 or less (overall) and 3 or less per organ system receive 6 cycles of B-CAP (Brentuximab vedotin, cyclophosphamide, doxorubicine, predniso(lo)ne). Cycle length is 21 days |
| Brentoximab Vedotin only | Experimental | Drug: Brentuximab VedotinPatients with CIRS-G score of 7 ore more receive Brentuximab Vedotin as single agent therapy for up to 16 cycles. Cycle length is 21 days |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- classical Hodgkin Lymphoma
- Age 60 years or older
- ECOG performance status ≤ 2 or ≤ 3 if due to HL
- CIRS-G score of ≤ 6 and ≤ 3 per organ system (except score 4 for eye, ear, nose and throat)
- Advanced stages: Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV disease
Key exclusion criteria (6 listed)
- Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
- Prior chemotherapy or radiation for HL except prephase
- Peripheral neuropathy greater than CTC Grade 1
- Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
- Prior chemotherapy or radiation for HL except prephase as outlined in the protocol
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 |
|---|---|---|
| B-CAPAlso: Brentuximab Vedotin, Cyclophosphamide, Doxorubicine, Predniso(lo)ne | Drug | B-CAP |
| Brentuximab Vedotin | Drug | Brentoximab Vedotin only |
Primary outcome
Objective response rate
Time frame: after 6 cycles of therapy (at least 18 weeks after start of treatment)
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 23 Aug 2024.
- Homepage GHSGLink 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.
Peter Borchmann, Prof. principal investigator
University Hospital 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 B-CAP and Brentuximab Vedotin 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 12 inclusion and 6 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 23 Aug 2024. 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?
Objective response rate (time frame: after 6 cycles of therapy (at least 18 weeks after start of treatment)). 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 23 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.