Lymphoma, FollicularPhase 1/2NCT00092274
Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular Lymphoma
A Phase 1/2 study testing HuMax-CD20 in people with Lymphoma, Follicular, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Follicular Lymphoma (FL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Follicular
- What is being tested?
- HuMax-CD20
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jan 2005
- Phase
- Phase 1/2
- 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
- Relapsed or refractory follicular lymphoma grade I-II
- Tumor verified to be CD20 positive
- CT scan showing demarcated lesions
Who cannot join
- Previous treatment with rituximab resulting in less than partial response
- Previous radioimmunotherapy
- Previous stem cell transplantation
- Received the following treatments within 4 weeks prior to entering this study:
- Anti-cancer therapy
- Glucocorticosteroids unless less than 10 mg prednisolone/day
Show all 18Show fewer
- Radiotherapy
- Received Mitomycin C or Nitrosoureas within 6 weeks prior to entering this trial
- HIV positivity
- Hepatitis B or hepatitis C
- Uncontrolled or chronic bacterial, fungal or viral infection
- Other cancer diseases, except certain skin cancers, cervix cancer and breast cancer
- Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases
- WHO performance status of 3 or 4
- If you are participating in another trial with a different new drug 4 weeks before you enter this trial
- Current participation in any other clinical study
- Pregnant or breast-feeding women
- Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: An Open-label, International, Multicenter, Dose Escalating, Phase I/II Study of HuMax-CD20 in Patients With Relapsed or Refractory Follicular Lymphoma Grade I-II
The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Follicular Lymphoma (FL).
- Conditions
- Lymphoma, Follicular
- Being tested
- HuMax-CD20
- Keywords
- Follicular Lymphoma, Non Hodgkin´s Lymphoma
- Medical subject headings
- Lymphoma, Follicular, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HuMax-CD20Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2004 (estimated)
- Study startSep 2004
- Primary completionJan 2005
- Study completionJan 2005
Why it stopped: Acquired asset
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, FollicularStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00092274
- Sponsor's protocol ID
- Hx-CD20-001
- Status last verified
- Jan 2005
- First submitted
- 22 Sep 2004
- Last updated
- 21 Apr 2015
- Results posted
- No
Publications
Struemper H, Sale M, Patel BR, Ostergaard M, Osterborg A, Wierda WG, Hagenbeek A, Coiffier B, Jewell RC. Population pharmacokinetics of ofatumumab in patients with chronic lymphocytic leukemia, follicular lymphoma, and rheumatoid arthritis. J Clin Pharmacol. 2014 Jul;54(7):818-27. doi: 10.1002/jcph.268. Epub 2014 Jan 28.
PubMed 24443277Hagenbeek A, Gadeberg O, Johnson P, Pedersen LM, Walewski J, Hellmann A, Link BK, Robak T, Wojtukiewicz M, Pfreundschuh M, Kneba M, Engert A, Sonneveld P, Flensburg M, Petersen J, Losic N, Radford J. First clinical use of ofatumumab, a novel fully human anti-CD20 monoclonal antibody in relapsed or refractory follicular lymphoma: results of a phase 1/2 trial. Blood. 2008 Jun 15;111(12):5486-95. doi: 10.1182/blood-2007-10-117671. Epub 2008 Apr 4.
PubMed 18390837
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, International, Multicenter, Dose Escalating, Phase I/II Study of HuMax-CD20 in Patients With Relapsed or Refractory Follicular Lymphoma Grade I-II
- ClinicalTrials.gov ID
- NCT00092274
- Acronym / sponsor ID
- Hx-CD20-001
- Conditions
- Lymphoma, Follicular
- Keywords
- Follicular Lymphoma, Non Hodgkin´s Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Acquired asset
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 27 Sep 2004 (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 safety and efficacy of HuMax-CD20 as a treatment for Follicular Lymphoma (FL).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Relapsed or refractory follicular lymphoma grade I-II
- Tumor verified to be CD20 positive
- CT scan showing demarcated lesions
Key exclusion criteria (18 listed)
- Previous treatment with rituximab resulting in less than partial response
- Previous radioimmunotherapy
- Previous stem cell transplantation
- Received the following treatments within 4 weeks prior to entering this study:
- Received Mitomycin C or Nitrosoureas within 6 weeks prior to entering this trial
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-CD20 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
- Derived from this study: PubMed 24443277Struemper H, Sale M, Patel BR, Ostergaard M, Osterborg A, Wierda WG, Hagenbeek A, Coiffier B, Jewell RC. Population pharmacokinetics of ofatumumab in patients with chronic lymphocytic leukemia, follicular lymphoma, and rheumatoid arthritis. J Clin Pharmacol. 2014 Jul;54(7):818-27. doi: 10.1002/jcph.268. Epub 2014 Jan 28.
- Derived from this study: PubMed 18390837Hagenbeek A, Gadeberg O, Johnson P, Pedersen LM, Walewski J, Hellmann A, Link BK, Robak T, Wojtukiewicz M, Pfreundschuh M, Kneba M, Engert A, Sonneveld P, Flensburg M, Petersen J, Losic N, Radford J. First clinical use of ofatumumab, a novel fully human anti-CD20 monoclonal antibody in relapsed or refractory follicular lymphoma: results of a phase 1/2 trial. Blood. 2008 Jun 15;111(12):5486-95. doi: 10.1182/blood-2007-10-117671. Epub 2008 Apr 4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HuMax-CD20 in people with Lymphoma, Follicular, run by GlaxoSmithKline at 1 site in United States.
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 18 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: withdrawn, as of the sponsor's last update on 21 Apr 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 United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00092274, which also lists 2 linked publications.
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 21 Apr 2015.