NHLPhase 1NCT02847949
A Study of IGN002 for Refractory NHL
A Phase 1 study testing IGN002 in people with NHL, run by Spectrum Pharmaceuticals, Inc at 1 site in United States.
Trial summary
This is a Phase 1 multi-center, open-label study that allows subjects who derived clinical benefit after completing IGN002 treatment in the Spectrum sponsored IGN002-101 study to continue treatment with IGN002. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NHL
- What is being tested?
- IGN002
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2021to Dec 2025
- 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
- Currently enrolled in Spectrum sponsored IGN002 study, IGN002-101
- Derived clinical benefit from IGN002, defined as CR, PR, or SD, in IGN002-101 study
- Tolerated IGN002 therapy in the other Spectrum sponsored IGN002 study
- Female subject is post-menopausal (no menstrual period for a minimum of 12 months) or surgically sterilized and has a negative serum pregnancy test upon entry. Women of childbearing potential (WOCBP) must use an oral or implanted contraceptive, a double barrier method of birth control or an intrauterine device upon enrollment through 3 months after receiving the last dose of IP. Male subject is surgically sterile or is willing to use contraception upon enrollment through 3 months after receiving the last dose of IP.
- Able and willing to provide informed consent
Who cannot join
- Discontinued from other Spectrum sponsored IGN002 study, IGN002-101 due to an AE considered by the Investigator to be related to IGN002 treatment
- Experienced PD during participation in other Spectrum sponsored study, IGN002-101
- Pregnant or nursing
- Concurrent medical condition that precludes safe participation in this study
- Active viral hepatitis infection. Subjects with history of hepatitis infection that is not active are eligible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Extension Study of Multiple Intravenous Doses of IGN002 Administered Weekly to Subjects With Refractory Non-Hodgkin Lymphoma (NHL)
This is a Phase 1 multi-center, open-label study that allows subjects who derived clinical benefit after completing IGN002 treatment in the Spectrum sponsored IGN002-101 study to continue treatment with IGN002. Subjects who completed the IGN002-101 study, tolerated IGN002 treatment, and did not experience progressive disease (PD) are eligible to participate in this study.
Read the detailed description
In this extension study, IGN002 study drug will initially be administered at the same dose level and schedule that the subject was receiving at the conclusion of the Spectrum sponsored IGN002-101 study. If additional safety and PK data from another Spectrum sponsored IGN002 study support a higher dose level that is deemed safe and well tolerated by the Safety Review Committee (SRC), the dose of IGN002 may be increased within a given subject. However, dose levels of IGN002 in this extension study may not exceed the maximum tolerated dose (MTD). In addition, the dose for a given subject may be lowered per Investigator discretion. Each treatment cycle comprises a total of 8 doses of IGN002 administered at weekly intervals.
Subjects will be evaluated at the study clinic before each dose of IGN002. At each study visit, standard of care assessments will be performed, which will include physical examination, measurement of vital signs, documentation of adverse events (AEs) and concomitant medications, and laboratory analyses of blood and urine. Radiological assessments will be performed at the end of each 8-week cycle. Tumor status will be assessed by comparison to the subject's baseline tumor status, as determined in the separate study, IGN002-101, or tumor nadir, if the subject has demonstrated response.
Reasons for subject withdrawal include PD in subjects not deriving clinical benefit from IGN002 therapy or clinically significant IGN002-related AEs. If a subject discontinues the study for any reason, an early termination (ET) visit will be conducted 30 (±3) days after the last dose of IGN002. This visit will include physical examination, vital sign measurements, laboratory analyses of blood and urine, and documentation of AEs and concomitant medications.
- Conditions
- NHL
- Being tested
- IGN002
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGN002Biological
IGN002 is a monoclonal antibody fusion protein
| Study group | Role | What they receive |
|---|---|---|
| Extension arm | Experimental | IGN002 study drug will initially be administered at the same dose level and schedule that the subject was receiving at the conclusion of the other Spectrum sponsored IGN002 study, IGN002-101. Receives: Biological: IGN002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the incidence of adverse events following multiple doses of IGN002 administered weekly as an IV infusion to subjects with refractory NHL
Adverse Event collection and assessment will be done to assess the safety and tolerability of IGN002
Measured: An average of 1 year.
Secondary outcomes (2)
Duration of response to IGN002 using the Lugano Classification for NHL
Lugano Classification Criteria for NHL will be used to assess the duration of response to IGN002
Measured: Through study completion, an average of 1 year.
Overall response rate of the therapeutic agent in NHL patients.
Overall response rate following IGN002 treatment will be assessed
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startJan 2021 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Strategic Reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NHLStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Leukemia and Lymphoma Society
- Responsible party
- Sponsor
- Investigators
- John Timmerman, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847949
- Sponsor's protocol ID
- IGN002-201
- Status last verified
- Feb 2022
- First submitted
- 12 Jul 2016
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Extension Study of Multiple Intravenous Doses of IGN002 Administered Weekly to Subjects With Refractory Non-Hodgkin Lymphoma (NHL)
- ClinicalTrials.gov ID
- NCT02847949
- Acronym / sponsor ID
- IGN002-201
- Conditions
- NHL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Strategic Reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- The Leukemia and Lymphoma Society
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Jul 2016 (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.
This is a Phase 1 multi-center, open-label study that allows subjects who derived clinical benefit after completing IGN002 treatment in the Spectrum sponsored IGN002-101 study to continue treatment with IGN002. Subjects who completed the IGN002-101 study, tolerated IGN002 treatment, and did not experience progressive disease (PD) are eligible to participate in this study.
Detailed description
In this extension study, IGN002 study drug will initially be administered at the same dose level and schedule that the subject was receiving at the conclusion of the Spectrum sponsored IGN002-101 study. If additional safety and PK data from another Spectrum sponsored IGN002 study support a higher dose level that is deemed safe and well tolerated by the Safety Review Committee (SRC), the dose of IGN002 may be increased within a given subject. However, dose levels of IGN002 in this extension study may not exceed the maximum tolerated dose (MTD). In addition, the dose for a given subject may be lowered per Investigator discretion. Each treatment cycle comprises a total of 8 doses of IGN002 administered at weekly intervals.
Subjects will be evaluated at the study clinic before each dose of IGN002. At each study visit, standard of care assessments will be performed, which will include physical examination, measurement of vital signs, documentation of adverse events (AEs) and concomitant medications, and laboratory analyses of blood and urine. Radiological assessments will be performed at the end of each 8-week cycle. Tumor status will be assessed by comparison to the subject's baseline tumor status, as determined in the separate study, IGN002-101, or tumor nadir, if the subject has demonstrated response.
Reasons for subject withdrawal include PD in subjects not deriving clinical benefit from IGN002 therapy or clinically significant IGN002-related AEs. If a subject discontinues the study for any reason, an early termination (ET) visit will be conducted 30 (±3) days after the last dose of IGN002. This visit will include physical examination, vital sign measurements, laboratory analyses of blood and urine, and documentation of AEs and concomitant medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extension arm | Experimental | Biological: IGN002IGN002 study drug will initially be administered at the same dose level and schedule that the subject was receiving at the conclusion of the other Spectrum sponsored IGN002 study, IGN002-101. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Currently enrolled in Spectrum sponsored IGN002 study, IGN002-101
- Derived clinical benefit from IGN002, defined as CR, PR, or SD, in IGN002-101 study
- Tolerated IGN002 therapy in the other Spectrum sponsored IGN002 study
- Female subject is post-menopausal (no menstrual period for a minimum of 12 months) or surgically sterilized and has a negative serum pregnancy test upon entry. Women of childbearing potential (WOCBP) must use an oral or implanted contraceptive, a double barrier method of birth control or an intrauterine device upon enrollment through 3 months after receiving the last dose of IP. Male subject is surgically sterile or is willing to use contraception upon enrollment through 3 months after receiving the last dose of IP.
- Able and willing to provide informed consent
Key exclusion criteria (5 listed)
- Discontinued from other Spectrum sponsored IGN002 study, IGN002-101 due to an AE considered by the Investigator to be related to IGN002 treatment
- Experienced PD during participation in other Spectrum sponsored study, IGN002-101
- Pregnant or nursing
- Concurrent medical condition that precludes safe participation in this study
- Active viral hepatitis infection. Subjects with history of hepatitis infection that is not active are eligible.
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 |
|---|---|---|
| IGN002IGN002 is a monoclonal antibody fusion protein | Biological | Extension arm |
Primary outcome
To evaluate the incidence of adverse events following multiple doses of IGN002 administered weekly as an IV infusion to subjects with refractory NHL
Time frame: An average of 1 year.
Adverse Event collection and assessment will be done to assess the safety and tolerability of IGN002
2 secondary outcomes
Duration of response to IGN002 using the Lugano Classification for NHL
Time frame: Through study completion, an average of 1 year.
Overall response rate of the therapeutic agent in NHL patients.
Time frame: Through study completion, an average of 1 year.
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 11 Mar 2022.
- Individual participant dataSharing planned: No
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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.
John Timmerman principal investigator
University of California, Los Angeles
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 IGN002 in people with NHL, run by Spectrum Pharmaceuticals, Inc 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 5 inclusion and 5 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 11 Mar 2022. 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 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.
What does the primary outcome measure?
To evaluate the incidence of adverse events following multiple doses of IGN002 administered weekly as an IV infusion to subjects with refractory NHL (time frame: An average of 1 year.). 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 11 Mar 2022.