T Cell LymphomaPhase 2/3NCT00877656
HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma
A Phase 2/3 study testing HuMax-CD4 in people with T Cell Lymphoma, run by Emergent BioSolutions.
Trial summary
The purpose of this study is to assess the safety and efficacy of treatment of non-cutaneous T-cell lymphoma with treatment with CD4. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T Cell Lymphoma
- What is being tested?
- HuMax-CD4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Dec 2008
- Phase
- Phase 2/3
- 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
- Diagnostic biopsy of non cutaneous T Cell lymphoma with positive phenotype
- Relapsed or refractory to minimum of one course of chemotherapy
- Study is closed to enrollment.
Who cannot join
None listed.
About this study
Official title: An Open-Label Therapeutic Exploratory Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients With Refractory or Relapsed Non-Cutaneous CD4+ T-Cell Lymphoma
The purpose of this study is to assess the safety and efficacy of treatment of non-cutaneous T-cell lymphoma with treatment with CD4.
Read the detailed description
The study is closed and all subjects have completed treatment.
The study is to evaluate the safety and efficacy of Humax CD4 with CHO vs CHO alone in subjects with non-cutaneous T cell lymphoma. The primary efficacy will be evaluated by time to relapse.
- Conditions
- T Cell Lymphoma
- Being tested
- HuMax-CD4
- Medical subject headings
- Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HuMax-CD4Biological
Active treatment
| Study group | Role | What they receive |
|---|---|---|
| CD4 | Experimental | Open label treatment arm Receives: Biological: HuMax-CD4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy as measured by survival and time to disease progression
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startAug 2005
- Primary completionJan 2006
- Study completionDec 2008
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 T Cell 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergent BioSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Abhay Patki, PhD, Study chair, Genmab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877656
- Sponsor's protocol ID
- Hx-CD4-109
- Status last verified
- Mar 2024
- First submitted
- 25 Mar 2009
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
d'Amore F, Radford J, Relander T, Jerkeman M, Tilly H, Osterborg A, Morschhauser F, Gramatzki M, Dreyling M, Bang B, Hagberg H. Phase II trial of zanolimumab (HuMax-CD4) in relapsed or refractory non-cutaneous peripheral T cell lymphoma. Br J Haematol. 2010 Sep;150(5):565-73. doi: 10.1111/j.1365-2141.2010.08298.x. Epub 2010 Jul 14.
PubMed 20629661
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Therapeutic Exploratory Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients With Refractory or Relapsed Non-Cutaneous CD4+ T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00877656
- Acronym / sponsor ID
- Hx-CD4-109
- Conditions
- T Cell Lymphoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Emergent BioSolutionsIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Jan 2006 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 8 Apr 2009 (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 study is to assess the safety and efficacy of treatment of non-cutaneous T-cell lymphoma with treatment with CD4.
Detailed description
The study is closed and all subjects have completed treatment.
The study is to evaluate the safety and efficacy of Humax CD4 with CHO vs CHO alone in subjects with non-cutaneous T cell lymphoma. The primary efficacy will be evaluated by time to relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD4 | Experimental | Biological: HuMax-CD4Open label treatment arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnostic biopsy of non cutaneous T Cell lymphoma with positive phenotype
- Relapsed or refractory to minimum of one course of chemotherapy
- Study is closed to enrollment.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| HuMax-CD4Active treatment | Biological | CD4 |
Primary outcome
Efficacy as measured by survival and time to disease progression
Time frame: 12 months
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 18 Mar 2024.
- Background: PubMed 20629661d'Amore F, Radford J, Relander T, Jerkeman M, Tilly H, Osterborg A, Morschhauser F, Gramatzki M, Dreyling M, Bang B, Hagberg H. Phase II trial of zanolimumab (HuMax-CD4) in relapsed or refractory non-cutaneous peripheral T cell lymphoma. Br J Haematol. 2010 Sep;150(5):565-73. doi: 10.1111/j.1365-2141.2010.08298.x. Epub 2010 Jul 14.
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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.
Abhay Patki, PhD study chair
Genmab
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing HuMax-CD4 in people with T Cell Lymphoma, run by Emergent BioSolutions.
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 0 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 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Efficacy as measured by survival and time to disease progression (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00877656, 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 18 Mar 2024.