Relapsed NLPHLPhase 2NCT01187303
Ofatumumab in Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)
A Phase 2 study testing Ofatumumab in people with Relapsed NLPHL, run by University of Cologne at 1 site in Germany.
Trial summary
The purpose of this trial is to determine the efficacy of ofatumumab in patients with relapsed nodular lymphocyte predominant Hodgkin lymphoma (NLPHL). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed NLPHL
- What is being tested?
- Ofatumumab
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- May 2011to Sep 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- relapsed nodular lymphocyte predominant hodgkin lymphoma
- age 18 - 75
- review of diagnosis by experienced pathologist
- no major organ dysfunction
Who cannot join
- classical hodgkin lymphoma
- CD20 antibody treatment within the last 6 months prior enrollment
- chronic or current infectious disease requirering systemic antibiotics
- other past or current malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ofatumumab in Relapsed Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)
The purpose of this trial is to determine the efficacy of ofatumumab in patients with relapsed nodular lymphocyte predominant Hodgkin lymphoma (NLPHL).
- Conditions
- Relapsed NLPHL
- Being tested
- Ofatumumab
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OfatumumabDrug
300 mg/m2 d1 week 1 1000mg/m2 d1 week 2-8
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: 12 months after end of treatment
Secondary outcomes (3)
duration of response
Measured: 12 months after end of treatment
Progression free survival
Measured: 12 months after end of treatment
adverse events
Measured: 12 months after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2010 (estimated)
- Study startMay 2011
- Primary completionNov 2013
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed NLPHLStudies 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Andreas Engert, University of Cologne
- Investigators
- Andreas Engert, MD, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187303
- Sponsor's protocol ID
- Uni-Koeln-1432
- Status last verified
- Oct 2015
- First submitted
- 19 Aug 2010
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ofatumumab in Relapsed Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)
- ClinicalTrials.gov ID
- NCT01187303
- Acronym / sponsor ID
- Uni-Koeln-1432
- Conditions
- Relapsed NLPHL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 24 Aug 2010 (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 the efficacy of ofatumumab in patients with relapsed nodular lymphocyte predominant Hodgkin lymphoma (NLPHL).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- relapsed nodular lymphocyte predominant hodgkin lymphoma
- age 18 - 75
- review of diagnosis by experienced pathologist
- no major organ dysfunction
Key exclusion criteria (4 listed)
- classical hodgkin lymphoma
- CD20 antibody treatment within the last 6 months prior enrollment
- chronic or current infectious disease requirering systemic antibiotics
- other past or current malignancy
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 |
|---|---|---|
| Ofatumumab300 mg/m2 d1 week 1 1000mg/m2 d1 week 2-8 | Drug | – |
Primary outcome
Overall response rate
Time frame: 12 months after end of treatment
3 secondary outcomes
duration of response
Time frame: 12 months after end of treatment
Progression free survival
Time frame: 12 months after end of treatment
adverse events
Time frame: 12 months after end 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 2 Nov 2015.
- Homepage of the German Hodgkin Study GroupLink provided by the sponsor.
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 Engert, MD 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 Ofatumumab in people with Relapsed NLPHL, 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 4 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 2 Nov 2015. 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?
Overall response rate (time frame: 12 months after end 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 2 Nov 2015.