Non-Hodgkin's LymphomaPhase 1NCT01768338
Recombinant Human IL-18 and Ofatumumab After PBSCT for Lymphoma
A Phase 1 study testing Ofatumumab combined with SB-485232 in people with Non-Hodgkin's Lymphoma, run by Michael John Robertson at 1 site in United States.
Trial summary
The purpose of this study is to test the safety of rhIL-18 combined with ofatumumab to see what effects (good and bad) it has on subjects and their non-Hodgkin's lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- Ofatumumab combined with SB-485232
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to 3 Aug 2017
- 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
- Patients who have undergone high-dose therapy and autologous PBSCT for treatment of CD20+ lymphoma.
- Patients must be between 2-6 months post-transplantation at the time of study registration.
- Patients must have at least stable disease (no overt progressive disease) at the time of study registration.
- Laboratory values must be within protocol specified ranges.
- Females of childbearing potential must have a negative pregnancy test.
- Females of childbearing potential and males must use an effective method of contraception from the time of consent until at least 365 days following discontinuation of protocol therapy.
Who cannot join
- Patient must not have obvious clinical progression of lymphoma after PBSCT as determined by the treating physician.
- Cannot be positive for hepatitis B surface antigen, hepatitis B core antibody or HIV antibody.
- No major or uncontrolled comorbid conditions as determined by the treating physician: history of ventricular arrhythmias requiring drug or device therapy; uncontrolled angina or symptomatic congestive heart failure; • severe or uncontrolled infection requiring systemic antibiotic or antifungal therapy or active hepatitis C infection; severe or uncontrolled psychiatric illness.
- No known leptomeningeal involvement by lymphoma or current metastatic brain disease.
- No Corrected QTc interval > 480 msec.
- No known or suspected hypersensitivity to ofatumumab or SB-485232 that in the opinion of the investigator is a contraindication to their participation in the study.
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- No systemic (oral or parenteral) corticosteroids within 14 days of study entry.
- Not receiving concurrent chemotherapy, biologic therapy, radiotherapy, or other investigational therapy.
- No previous treatment with SB-485232 or ofatumumab.
- No history of other malignancy except for adequately treated non-invasive cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix.
- No diabetes mellitus with poor glycemic control (documented hemoglobin A1c >7% within 4 weeks prior to study entry).
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: A Phase I Study of Recombinant Human Interleukin-18 (SB-485232) in Combination With Ofatumumab After Autologous Peripheral Blood Stem Cell Transplantation for Lymphoma
The purpose of this study is to test the safety of rhIL-18 combined with ofatumumab to see what effects (good and bad) it has on subjects and their non-Hodgkin's lymphoma.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- Ofatumumab combined with SB-485232
- 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.
Ofatumumab combined with SB-485232Drug
Ofatumumab with escalating doses of SB-485232
| Study group | Role | What they receive |
|---|---|---|
| Ofatumumab combined with SB-485232 | Experimental | Otatumumab: 1000 mg IV for 4 weeks. SB-485232: escalating doses (3 ug/kg up to 30 ug/kg) for 8 weeks. Receives: Drug: Ofatumumab combined with SB-485232 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the the number of subjects with adverse events who receive SB-485232 when given in combination with ofatumumab
Adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 which uses a scale of 1 (mild) to 5 (caused death).
Measured: 8 weeks
Secondary outcomes (1)
To evaluate the biologic effects of SB-485232 given in combination with ofatumumab
Biologic effects will be assessed by flow cytometric analysis of PBMCs and ELISA tests to measure plasma cytokines and chemokines.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2016
- Study completion3 Aug 2017
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael John Robertson
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor-investigator, Michael John Robertson, Indiana University
- Investigators
- Michael Robertson, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768338
- Sponsor's protocol ID
- IUCRO-0397
- Other IDs
- 1210009882
- Status last verified
- Feb 2023
- First submitted
- 9 Jan 2013
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Recombinant Human Interleukin-18 (SB-485232) in Combination With Ofatumumab After Autologous Peripheral Blood Stem Cell Transplantation for Lymphoma
- ClinicalTrials.gov ID
- NCT01768338
- Acronym / sponsor ID
- IUCRO-0397
- Conditions
- Non-Hodgkin's Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Michael John RobertsonUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Feb 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- 3 Aug 2017 (actual)
- First posted
- 15 Jan 2013 (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 test the safety of rhIL-18 combined with ofatumumab to see what effects (good and bad) it has on subjects and their non-Hodgkin's lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ofatumumab combined with SB-485232 | Experimental | Drug: Ofatumumab combined with SB-485232Otatumumab: 1000 mg IV for 4 weeks. SB-485232: escalating doses (3 ug/kg up to 30 ug/kg) for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who have undergone high-dose therapy and autologous PBSCT for treatment of CD20+ lymphoma.
- Patients must be between 2-6 months post-transplantation at the time of study registration.
- Patients must have at least stable disease (no overt progressive disease) at the time of study registration.
- Laboratory values must be within protocol specified ranges.
- Females of childbearing potential must have a negative pregnancy test.
Key exclusion criteria (11 listed)
- Patient must not have obvious clinical progression of lymphoma after PBSCT as determined by the treating physician.
- Cannot be positive for hepatitis B surface antigen, hepatitis B core antibody or HIV antibody.
- No major or uncontrolled comorbid conditions as determined by the treating physician: history of ventricular arrhythmias requiring drug or device therapy; uncontrolled angina or symptomatic congestive heart failure; • severe or uncontrolled infection requiring systemic antibiotic or antifungal therapy or active hepatitis C infection; severe or uncontrolled psychiatric illness.
- No known leptomeningeal involvement by lymphoma or current metastatic brain disease.
- No Corrected QTc interval > 480 msec.
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 |
|---|---|---|
| Ofatumumab combined with SB-485232Ofatumumab with escalating doses of SB-485232 | Drug | Ofatumumab combined with SB-485232 |
Primary outcome
To evaluate the the number of subjects with adverse events who receive SB-485232 when given in combination with ofatumumab
Time frame: 8 weeks
Adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 which uses a scale of 1 (mild) to 5 (caused death).
1 secondary outcome
To evaluate the biologic effects of SB-485232 given in combination with ofatumumab
Time frame: 8 weeks
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 10 Feb 2023.
- 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.
Michael Robertson, MD principal investigator
Indiana University
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 Ofatumumab combined with SB-485232 in people with Non-Hodgkin's Lymphoma, run by Michael John Robertson 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 6 inclusion and 11 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 10 Feb 2023. 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 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?
To evaluate the the number of subjects with adverse events who receive SB-485232 when given in combination with ofatumumab (time frame: 8 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 10 Feb 2023.