Classical Hodgkin LymphomaPhase 2NCT03652441
Consolidation Therapy With Brentuximab Vedotin After Allogeneic Stem Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma
A Phase 2 study testing Brentuximab Vedotin in people with Classical Hodgkin Lymphoma, run by University of Cologne at 1 site in Germany.
Trial summary
The aim of the trial is to improve disease control after an allogeneic stem cell transplantation (alloSCT) for relapsed or refractory classical Hodgkin lymphoma (rrHL, cHL) with consolidation therapy by Brentuximab Vedotin (BV) for up to one year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Classical Hodgkin Lymphoma
- What is being tested?
- Brentuximab Vedotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- 13 Nov 2019to 25 Jan 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with relapsed/refractory cHL who receive an allogeneic stem cell transplantation
- Histologically proven cHL in the most recent tumor biopsy
- Absolute neutrophil count ≥ 500/mm³
- ECOG ≤2
- Age ≥ 18 years
Who cannot join
- Presence of nodular lymphocyte-predominant HL (NLPHL) or grey-zone lymphoma
- Progressive disease as last documented response prior to alloSCT
- Any peripheral neuropathy ≥ grade 2
- Any other serious disease or organ dysfunction which might impair protocol treatment
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the trial is to improve disease control after an allogeneic stem cell transplantation (alloSCT) for relapsed or refractory classical Hodgkin lymphoma (rrHL, cHL) with consolidation therapy by Brentuximab Vedotin (BV) for up to one year.
The primary objective of the trial is to show efficacy of the experimental consolidative treatment strategy. Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.
- Conditions
- Classical Hodgkin Lymphoma
- Being tested
- Brentuximab Vedotin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brentuximab VedotinDrug
Also called BV
BV will be administered i.v. at 1.8mg/kg at 3-weekly intervals for up to 16 infusions
| Study group | Role | What they receive |
|---|---|---|
| Maintenance | Experimental | Brentuximab Vedotin will be administered i.v. at 1.8mg/kg at 3-weekly intervals for up to 16 infusions Receives: Drug: Brentuximab Vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year Cumulative incidence of relapse (CIR)
1-year Cumulative incidence of relapse (CIR)
Measured: 1 year
Secondary outcomes (1)
1- and 2-year Progression-free survival (PFS)
1- and 2-year Progression-free survival (PFS)
Measured: 1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start13 Nov 2019
- Primary completion10 Aug 2023
- Study completion25 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classical 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Scheid, University of Cologne
- Investigators
- Christof Scheid, Prof., Principal investigator, University of Cologne, I. Dept. of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652441
- Sponsor's protocol ID
- Uni-Koeln 3263
- Other IDs
- 2018-000873-59, 2018
- Status last verified
- Mar 2026
- First submitted
- 28 Aug 2018
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consolidation Therapy With Brentuximab Vedotin After Allogeneic Stem Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT03652441
- Acronym / sponsor ID
- Uni-Koeln 3263
- Conditions
- Classical Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 25 Jan 2025 (actual)
- First posted
- 29 Aug 2018 (actual)
- 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 aim of the trial is to improve disease control after an allogeneic stem cell transplantation (alloSCT) for relapsed or refractory classical Hodgkin lymphoma (rrHL, cHL) with consolidation therapy by Brentuximab Vedotin (BV) for up to one year.
The primary objective of the trial is to show efficacy of the experimental consolidative treatment strategy. Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maintenance | Experimental | Drug: Brentuximab VedotinBrentuximab Vedotin will be administered i.v. at 1.8mg/kg at 3-weekly intervals for up to 16 infusions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with relapsed/refractory cHL who receive an allogeneic stem cell transplantation
- Histologically proven cHL in the most recent tumor biopsy
- Absolute neutrophil count ≥ 500/mm³
- ECOG ≤2
- Age ≥ 18 years
Key exclusion criteria (4 listed)
- Presence of nodular lymphocyte-predominant HL (NLPHL) or grey-zone lymphoma
- Progressive disease as last documented response prior to alloSCT
- Any peripheral neuropathy ≥ grade 2
- Any other serious disease or organ dysfunction which might impair protocol treatment
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 |
|---|---|---|
| Brentuximab VedotinAlso: BVBV will be administered i.v. at 1.8mg/kg at 3-weekly intervals for up to 16 infusions | Drug | Maintenance |
Primary outcome
1-year Cumulative incidence of relapse (CIR)
Time frame: 1 year
1-year Cumulative incidence of relapse (CIR)
1 secondary outcome
1- and 2-year Progression-free survival (PFS)
Time frame: 1 and 2 years
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 5 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Classical Hodgkin Lymphoma
RecruitingPhase 3
A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
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Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)
Hodgkin Lymphoma
Active, not recruitingPhase 1
Pembrolizumab and Vorinostat in Patients With Relapsed or Refractory DLBCL, FCL or HL.
Grade 3b Follicular Lymphoma, Recurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between DLBCL and Classic HL
Active, not recruitingPhase 3
Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma
Ann Arbor Stage IIB Hodgkin Lymphoma, Ann Arbor Stage IIIB Hodgkin Lymphoma
RecruitingPhase 1/2
Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma
Hodgkin Lymphoma
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.
Christof Scheid, Prof. principal investigator
University of Cologne, I. Dept. of Medicine
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 Brentuximab Vedotin in people with Classical 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 5 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 5 Mar 2026. 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?
1-year Cumulative incidence of relapse (CIR) (time frame: 1 year). 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 5 Mar 2026.