Lymphoma, Non-HodgkinPhase 1NCT00347971
Study of Recombinant Interleukin 21 in Combination With Rituxan for Non-Hodgkin's Lymphoma
A Phase 1 study testing recombinant human interleukin 21 and rituximab in people with Lymphoma, Non-Hodgkin, run by ZymoGenetics at 1 site in United States.
Trial summary
The purpose of the study is to evaluate whether recombinant IL-21 used in combination with rituximab is safe for patients with non-Hodgkin's lymphoma (NHL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- recombinant human interleukin 21 and rituximab
- Type of treatment
- Injection or infusion
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Apr 2008
- 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
- Diagnosis of CD20+ B-cell NHL
- Disease measurable by computed tomography (CT) scan
- Has failed at least one prior systemic therapy for NHL
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate hepatic and renal function
- Adequate bone marrow function
Who cannot join
- Presence of acute infection or other significant systemic illness
- White blood cell (WBC) count > 50,000/mm3 in peripheral blood
- Central nervous system involvement by malignancy
- Previous allogenic transplant or autotransplant within 6 months of enrollment
- Other current malignancy or known history of cancer within 5 years
- Received systemic corticosteroids, chemotherapy, immunotherapy, biologic therapy, antibody therapy (e.g., rituximab), radiation therapy, and/or investigational agent(s) within 1 month of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: Phase 1, Open-Label, Dose-Escalation Study to Assess the Safety and Pharmacokinetics of Recombinant Interleukin 21 (rIL-21) Administered in Combination With Rituxan (Rituximab) in Subjects With B-Cell Non Hodgkin's Lymphoma
The purpose of the study is to evaluate whether recombinant IL-21 used in combination with rituximab is safe for patients with non-Hodgkin's lymphoma (NHL).
Read the detailed description
This is a Phase 1 open-label dose-escalation study of rituximab + rIL-21 combination therapy, administered once weekly for 4 weeks following an initial treatment with one dose of rituximab alone to patients with B-cell non-Hodgkin's lymphoma (NHL) who have failed prior therapy(ies). A standard dose of rituximab will be used. Increasing doses of rIL-21 will be studied sequentially in different groups of patients, starting with 30 μg/kg.
Before starting treatment with rituximab + rIL-21, patients will be treated with one dose of rituximab alone to look for rituximab infusion-related symptoms (such as fever, chills, and rigors). Patients who have severe infusion-related side effects after the first dose of rituximab will not go on to receive IL-21. Those who do not have unacceptable rituximab-related side effects will receive intravenous rIL-21 at least 60 minutes after completing the rituximab infusion at the rest of the weekly dosing visits. Patients will be evaluated for safety over the course of the study. Disease evaluation (tumor restaging) will be performed 2 weeks following completion of the first 4-week treatment cycle. Patients with stable disease or better at this evaluation may go on to receive a second 4-week treatment cycle of rituximab + rIL-21. Patients may be in the study for 2 to 4 months.
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- recombinant human interleukin 21 and rituximab
- Keywords
- Lymphoma, Non-Hodgkin, interleukin-21, rituximab, Immunotherapy
- 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.
recombinant human interleukin 21 and rituximabDrug
Also called rituxan
rIL-21 (30, 100, 150 ug/kg) IV rituximab (375 mg/m2) IV
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events through 1 month after completing treatment
Measured: During treatment and through 1 month after completing treatment
Incidence and grade of clinical laboratory abnormalities through 1 month after treatment
Measured: During treatment and through 1 month after completing treatment
Secondary outcomes (2)
Disease response by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas 2 weeks after completion of the first treatment cycle
Measured: Two and four weeks after completion of the first and second cycles, respectively
Immunogenicity by incidence of anti-rIL-21 antibodies up to 1 month after treatment
Measured: During treatment and up to 1 month after completing treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZymoGenetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Muriel Siadak, PA-C, Study director, ZymoGenetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347971
- Sponsor's protocol ID
- 494E03
- Status last verified
- Sep 2008
- First submitted
- 30 Jun 2006
- Last updated
- 5 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-Label, Dose-Escalation Study to Assess the Safety and Pharmacokinetics of Recombinant Interleukin 21 (rIL-21) Administered in Combination With Rituxan (Rituximab) in Subjects With B-Cell Non Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00347971
- Acronym / sponsor ID
- 494E03
- Conditions
- Lymphoma, Non-Hodgkin
- Keywords
- Lymphoma, Non-Hodgkin, interleukin-21, rituximab, Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- ZymoGeneticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 4 Jul 2006 (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 whether recombinant IL-21 used in combination with rituximab is safe for patients with non-Hodgkin's lymphoma (NHL).
Detailed description
This is a Phase 1 open-label dose-escalation study of rituximab + rIL-21 combination therapy, administered once weekly for 4 weeks following an initial treatment with one dose of rituximab alone to patients with B-cell non-Hodgkin's lymphoma (NHL) who have failed prior therapy(ies). A standard dose of rituximab will be used. Increasing doses of rIL-21 will be studied sequentially in different groups of patients, starting with 30 μg/kg.
Before starting treatment with rituximab + rIL-21, patients will be treated with one dose of rituximab alone to look for rituximab infusion-related symptoms (such as fever, chills, and rigors). Patients who have severe infusion-related side effects after the first dose of rituximab will not go on to receive IL-21. Those who do not have unacceptable rituximab-related side effects will receive intravenous rIL-21 at least 60 minutes after completing the rituximab infusion at the rest of the weekly dosing visits. Patients will be evaluated for safety over the course of the study. Disease evaluation (tumor restaging) will be performed 2 weeks following completion of the first 4-week treatment cycle. Patients with stable disease or better at this evaluation may go on to receive a second 4-week treatment cycle of rituximab + rIL-21. Patients may be in the study for 2 to 4 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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 (6 listed)
- Diagnosis of CD20+ B-cell NHL
- Disease measurable by computed tomography (CT) scan
- Has failed at least one prior systemic therapy for NHL
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate hepatic and renal function
Key exclusion criteria (6 listed)
- Presence of acute infection or other significant systemic illness
- White blood cell (WBC) count > 50,000/mm3 in peripheral blood
- Central nervous system involvement by malignancy
- Previous allogenic transplant or autotransplant within 6 months of enrollment
- Other current malignancy or known history of cancer within 5 years
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 |
|---|---|---|
| recombinant human interleukin 21 and rituximabAlso: rituxanrIL-21 (30, 100, 150 ug/kg) IV rituximab (375 mg/m2) IV | Drug | – |
Primary outcome
Incidence and severity of adverse events through 1 month after completing treatment
Time frame: During treatment and through 1 month after completing treatment
Incidence and grade of clinical laboratory abnormalities through 1 month after treatment
Time frame: During treatment and through 1 month after completing treatment
2 secondary outcomes
Disease response by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas 2 weeks after completion of the first treatment cycle
Time frame: Two and four weeks after completion of the first and second cycles, respectively
Immunogenicity by incidence of anti-rIL-21 antibodies up to 1 month after treatment
Time frame: During treatment and up to 1 month after completing treatment
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 5 Sep 2008.
Related trials for Lymphoma, Non-Hodgkin
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
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.
Muriel Siadak, PA-C study director
ZymoGenetics
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 recombinant human interleukin 21 and rituximab in people with Lymphoma, Non-Hodgkin, run by ZymoGenetics 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 6 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 5 Sep 2008. 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?
Incidence and severity of adverse events through 1 month after completing treatment (time frame: During treatment and through 1 month after completing treatment). The study lists 2 primary outcomes in all. 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 5 Sep 2008.