Non-Hodgkin's LymphomaPhase 1/2NCT00057447
Safety of Interferon Gamma-1b With Rituximab in Non-Hodgkin's Lymphoma Patients
A Phase 1/2 study testing Interferon Gamma-1b and Rituximab in people with Non-Hodgkin's Lymphoma, run by InterMune at 1 site in United States.
Trial summary
Evaluate the safety and efficacy of the dosing schedule of subcutaneous interferon gamma-1b (IFN g-1b) administered 3 times per week with Rituximab for 4 weeks, in patients with progressive or relapsed low-grade Non-Hodgkin's Lymphoma (NHL) International study with sites in the Czech Republic and Poland Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- Interferon Gamma-1b and Rituximab
- Type of treatment
- Injection or infusion
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Jun 2004
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Relapsed or progressive low-grade/follicular NHL who are candidates for rituximab therapy
- Patients who were on other therapy including CHOP or radiation
- Previous therapy must have concluded 30 days prior to enrollment
- Demonstrable CD20-positive tumor population in lymph nodes or bone marrow
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Study of the Safety of Subcutaneous Interferon Gamma-1b Combined With Rituximab in Patients With Low Grade/Follicular Non-Hodgkin's Lymphoma
Evaluate the safety and efficacy of the dosing schedule of subcutaneous interferon gamma-1b (IFN g-1b) administered 3 times per week with Rituximab for 4 weeks, in patients with progressive or relapsed low-grade Non-Hodgkin's Lymphoma (NHL)
International study with sites in the Czech Republic and Poland
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- Interferon Gamma-1b, Rituximab
- Keywords
- lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon Gamma-1bDrug
100 or 200 mcg, SQ, 3x per week
RituximabDrug
375 mg per square meters, IV, 1x per week
What is being measured
The primary outcome is the main question the study is designed to answer.
time to complete response (disappearance of all detectable clinical and radiographic evidenc of disease, and regression of lymph nodes)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2003 (estimated)
- Study startMar 2003
- Study completionJun 2004
Why it stopped: administrative reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- InterMune
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Williamson Bradford, MD, Study director, InterMune
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00057447
- Sponsor's protocol ID
- GINHL-001
- Status last verified
- Oct 2007
- First submitted
- 1 Apr 2003
- Last updated
- 1 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of the Safety of Subcutaneous Interferon Gamma-1b Combined With Rituximab in Patients With Low Grade/Follicular Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00057447
- Acronym / sponsor ID
- GINHL-001
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: administrative reasons
- Enrolment
- 24 participants (actual)
- Lead sponsor
- InterMuneIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Study completion
- Jun 2004 (actual)
- First posted
- 3 Apr 2003 (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.
Evaluate the safety and efficacy of the dosing schedule of subcutaneous interferon gamma-1b (IFN g-1b) administered 3 times per week with Rituximab for 4 weeks, in patients with progressive or relapsed low-grade Non-Hodgkin's Lymphoma (NHL)
International study with sites in the Czech Republic and Poland
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Interferon Gamma-1b100 or 200 mcg, SQ, 3x per week | Drug | – |
| Rituximab375 mg per square meters, IV, 1x per week | Drug | – |
Primary outcome
time to complete response (disappearance of all detectable clinical and radiographic evidenc of disease, and regression of lymph nodes)
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: administrative reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2007.
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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.
Williamson Bradford, MD study director
InterMune
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 Interferon Gamma-1b and Rituximab in people with Non-Hodgkin's Lymphoma, run by InterMune 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?
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 1 Nov 2007. 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 stopped early (reason given: administrative reasons). 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?
time to complete response (disappearance of all detectable clinical and radiographic evidenc of disease, and regression of lymph nodes) (time frame: 6 weeks). 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 1 Nov 2007.