Lymphoma, Non-Hodgkin'sPhase 1NCT00651443
Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma
A Phase 1 study testing Galiximab in people with Lymphoma, Non-Hodgkin's, run by Biogen at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the mechanism(s) of action of galiximab in subjects with previously untreated follicular NHL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin's
- What is being tested?
- Galiximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Dec 2010
- Phase
- Phase 1
- 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
- Written informed consent (signed and dated).
- Age equal or greater than 18 at the time of consent.
- Histologically confirmed follicular NHL according to the Revised European American Lymphoma (REAL)/ World Health Organization (WHO) classification (from initial diagnosis) Grades 1,2, or 3a.
- At least 2 malignant lymph nodes of similar size (>1 cm in minimal dimension) and location that are readily accessible for excisional biopsy at the time of study entry.
- Consent to 1 pretreatment and 1 post-treatment excisional biopsy of accessible tumor.
- Acceptable hematologic, hepatic, and renal function parameters.
- WHO Performance Status equal or less than 2.
- Subjects of reproductive potential must agree to follow accepted birth control methods.
Who cannot join
- Presence of lymphoma in CNS.
- Previous systemic anticancer treatment for NHL (including but not limited to radiation, myeloablative, or investigational therapy).
- Concurrent treatment with systemic steroids within 14 days of Day 1.
- Evidence of transformed lymphoma.
- Presence of malignancies within 3 years of Study Day 1 (except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, or basal or squamous cell skin cancer).
- History of HIV infection or AIDS.
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- Serious nonmalignant disease.
- Pregnant.
- Inability to comply with study and follow-up procedures.
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open Label Study to Evaluate the Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma
The purpose of the study is to evaluate the mechanism(s) of action of galiximab in subjects with previously untreated follicular NHL.
- Conditions
- Lymphoma, Non-Hodgkin's
- Being tested
- Galiximab
- Keywords
- galiximab, Untreated NHL, antibody, open-label
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GaliximabDrug
Galiximab 500 mg/m2 IV once weekly times 4, followed by Galiximab 500 mg/m2 IV once monthly times 4 as an extended dosing regimen.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Galiximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanism of action of galiximab given as a single agent in previously untreated subjects with follicular NHL.
Measured: 24 months
Secondary outcomes (1)
1) Safety and tolerability of Galiximab when administered as a single agent in an extended dosing regimen in previously untreated subjects with follicular NHL. 2) Evaluation of preliminary clinical activity of galiximab.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startAug 2008
- Primary completionNov 2010
- Study completionDec 2010
Why it stopped: A company's strategic decision to focus on areas whereit believes it can be competitive and decided to exit Oncology
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-Hodgkin'sStudies of the same condition, open and under way.
- More trials run by BiogenThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651443
- Sponsor's protocol ID
- 114-NH-103
- Status last verified
- Jan 2011
- First submitted
- 31 Mar 2008
- Last updated
- 7 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label Study to Evaluate the Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00651443
- Acronym / sponsor ID
- 114-NH-103
- Conditions
- Lymphoma, Non-Hodgkin's
- Keywords
- galiximab, Untreated NHL, antibody, open-label
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A company's strategic decision to focus on areas whereit believes it can be competitive and decided to exit Oncology
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 Apr 2008 (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 the study is to evaluate the mechanism(s) of action of galiximab in subjects with previously untreated follicular NHL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Galiximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent (signed and dated).
- Age equal or greater than 18 at the time of consent.
- Histologically confirmed follicular NHL according to the Revised European American Lymphoma (REAL)/ World Health Organization (WHO) classification (from initial diagnosis) Grades 1,2, or 3a.
- At least 2 malignant lymph nodes of similar size (>1 cm in minimal dimension) and location that are readily accessible for excisional biopsy at the time of study entry.
- Consent to 1 pretreatment and 1 post-treatment excisional biopsy of accessible tumor.
Key exclusion criteria (10 listed)
- Presence of lymphoma in CNS.
- Previous systemic anticancer treatment for NHL (including but not limited to radiation, myeloablative, or investigational therapy).
- Concurrent treatment with systemic steroids within 14 days of Day 1.
- Evidence of transformed lymphoma.
- Presence of malignancies within 3 years of Study Day 1 (except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, or basal or squamous cell skin cancer).
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 |
|---|---|---|
| GaliximabGaliximab 500 mg/m2 IV once weekly times 4, followed by Galiximab 500 mg/m2 IV once monthly times 4 as an extended dosing regimen. | Drug | 1 |
Primary outcome
Mechanism of action of galiximab given as a single agent in previously untreated subjects with follicular NHL.
Time frame: 24 months
1 secondary outcome
1) Safety and tolerability of Galiximab when administered as a single agent in an extended dosing regimen in previously untreated subjects with follicular NHL. 2) Evaluation of preliminary clinical activity of galiximab.
Time frame: 48 months
Results and safety
The study was stopped early (reason given: A company's strategic decision to focus on areas whereit believes it can be competitive and decided to exit Oncology). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2011.
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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 study testing Galiximab in people with Lymphoma, Non-Hodgkin's, run by Biogen 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 8 inclusion and 10 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: stopped early, as of the sponsor's last update on 7 Jan 2011. 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 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.
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 stopped early (reason given: A company's strategic decision to focus on areas whereit believes it can be competitive and decided to exit Oncology). Results are not available in the source record.
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?
Mechanism of action of galiximab given as a single agent in previously untreated subjects with follicular NHL. (time frame: 24 months). 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 7 Jan 2011.