Marginal Zone LymphomaPhase 2NCT00453102
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma
A Phase 2 study testing Rituximab and Ibritumomab Tiuxetan in people with Marginal Zone Lymphoma, run by University of Miami at 1 site in United States.
Trial summary
Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL). Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Marginal Zone Lymphoma
- What is being tested?
- Rituximab and Ibritumomab Tiuxetan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Feb 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old with previously untreated, histologically confirmed Marginal Zone Lymphoma (non-gastric extranodal MZL, splenic MZL and nodal MZL) or gastric MZL that did not respond to antibiotic therapy given up to 6 months prior to enrollment, but not less than 2 months)
- Measurable and evaluable disease
- All stages are eligible
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (Appendix B)
- Willing and able to provide written informed consent
- Women of childbearing potential must have a negative pregnancy test at study entry and must agree to use effective contraception while on treatment and for 6 months after treatment
- Life expectancy of at least 6 months
Who cannot join
- Prior chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids, or systemic biologic anticancer therapy before beginning study treatment.
- ≥ 25% lymphoma bone marrow involvement
- Platelet count < 100,000 cells/mm³
- Neutrophil count < 1,500 cells/mm³
- Known history of HIV infection
- Pregnant or lactating (pregnancy test is required for all female patients of childbearing potential)
- Woman of childbearing potential or sexually active man unwilling to use adequate contraceptive protection.
- Physical or mental condition that makes patient unable to complete specified follow-up assessments
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, 33136
About this study
Official title: Phase II Study of Ibritumomab Tiuxetan (Zevalin®) in Patients With Previously Untreated Marginal Zone Lymphoma
Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).
Read the detailed description
This phase II study will assess the clinical response rate to Ibritumomab Tiuxetan in patients with untreated nodal, splenic and non-gastric extranodal MZL as well as in antibiotic resistant patients with mucosa-associated lymphoid tissue (MALT) gastric lymphoma.
- Conditions
- Marginal Zone Lymphoma
- Being tested
- Rituximab, Ibritumomab Tiuxetan
- Keywords
- Marginal Zone Lymphoma, Non-gastric extranodal Marginal Zone Lymphoma, Splenic Marginal Zone Lymphoma, Nodal Marginal Zone Lymphoma, Gastric Marginal Zone Lymphoma, MZL, Non-gastric extranodal MZL, Splenic MZL, Nodal MZL, Gastric MZL
- Medical subject headings
- Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Rituxan, IDEC-C2B8, Chimeric anti-CD20 monoclonal antibody
IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Ibritumomab TiuxetanDrug
Also called Zevalin
IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
| Study group | Role | What they receive |
|---|---|---|
| Zevalin + Rituximab | Experimental | Ibritumomab Tiuxetan (Zevalin) + Rituximab Receives: Drug: Rituximab; Drug: Ibritumomab Tiuxetan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy.
The overall response rate (ORR) including complete response (CR), complete response unconfirmed (CRu), and partial response (PR) in participants receiving protocol therapy.
Measured: 12 weeks post-therapy
Secondary outcomes (5)
Rate of Progression-Free Survival
The time from the start of protocol therapy until the first documented or confirmed disease progression, or death related to study disease, whichever is earlier.
Measured: End of study.
5-Year Rate of Progression-Free Survival (5-Year PFS)
Percentage of participants still alive without disease progression five years after the date of protocol therapy initiation.
Measured: 5 Years
Overall Survival (OS) Rate
The time from the date of initiation of study treatment until date of death from any cause for all participants.
Measured: End of Study
5 Year Rate of Overall Survival (5-Year OS)
Percentage of participants still alive five years after the date of protocol therapy initiation.
Measured: 5 Years
Number of Participants With Unacceptable Toxicity.
Number of participants with treatment-related (possible, probable, or definite) grade 3 or higher non-hematologic adverse events.
Measured: Up to 12 weeks post-therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2007 (estimated)
- Study startFeb 2006
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Marginal Zone LymphomaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Izidore Lossos, University of Miami
- Investigators
- Izidore S. Lossos, MD, Study chair, University of Miami Sylvester Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453102
- Sponsor's protocol ID
- 20060078
- Other IDs
- SCCC-2005133, WIRB-20060249
- Status last verified
- Nov 2015
- First submitted
- 27 Mar 2007
- Last updated
- 1 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lossos IS, Fabregas JC, Koru-Sengul T, Miao F, Goodman D, Serafini AN, Hosein PJ, Stefanovic A, Rosenblatt JD, Hoffman JE. Phase II study of (90)Y Ibritumomab tiuxetan (Zevalin) in patients with previously untreated marginal zone lymphoma. Leuk Lymphoma. 2015 Jun;56(6):1750-5. doi: 10.3109/10428194.2014.975801. Epub 2014 Nov 20.
PubMed 25315074
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Ibritumomab Tiuxetan (Zevalin®) in Patients With Previously Untreated Marginal Zone Lymphoma
- ClinicalTrials.gov ID
- NCT00453102
- Acronym / sponsor ID
- 20060078
- Conditions
- Marginal Zone Lymphoma
- Keywords
- Marginal Zone Lymphoma, Non-gastric extranodal Marginal Zone Lymphoma, Splenic Marginal Zone Lymphoma, Nodal Marginal Zone Lymphoma, Gastric Marginal Zone Lymphoma, MZL, Non-gastric extranodal MZL, Splenic MZL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 28 Mar 2007 (estimated)
- Results
- Posted 1 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).
Detailed description
This phase II study will assess the clinical response rate to Ibritumomab Tiuxetan in patients with untreated nodal, splenic and non-gastric extranodal MZL as well as in antibiotic resistant patients with mucosa-associated lymphoid tissue (MALT) gastric lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zevalin + Rituximab | Experimental | Drug: Rituximab, Drug: Ibritumomab TiuxetanIbritumomab Tiuxetan (Zevalin) + Rituximab |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 18 years old with previously untreated, histologically confirmed Marginal Zone Lymphoma (non-gastric extranodal MZL, splenic MZL and nodal MZL) or gastric MZL that did not respond to antibiotic therapy given up to 6 months prior to enrollment, but not less than 2 months)
- Measurable and evaluable disease
- All stages are eligible
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (Appendix B)
- Willing and able to provide written informed consent
Key exclusion criteria (8 listed)
- Prior chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids, or systemic biologic anticancer therapy before beginning study treatment.
- ≥ 25% lymphoma bone marrow involvement
- Platelet count < 100,000 cells/mm³
- Neutrophil count < 1,500 cells/mm³
- Known history of HIV infection
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 |
|---|---|---|
| RituximabAlso: Rituxan, IDEC-C2B8, Chimeric anti-CD20 monoclonal antibodyIV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³ | Drug | Zevalin + Rituximab |
| Ibritumomab TiuxetanAlso: ZevalinIV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9: 0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³ | Drug | Zevalin + Rituximab |
Primary outcome
Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy.
Time frame: 12 weeks post-therapy
The overall response rate (ORR) including complete response (CR), complete response unconfirmed (CRu), and partial response (PR) in participants receiving protocol therapy.
5 secondary outcomes
Rate of Progression-Free Survival
Time frame: End of study.
5-Year Rate of Progression-Free Survival (5-Year PFS)
Time frame: 5 Years
Overall Survival (OS) Rate
Time frame: End of Study
5 Year Rate of Overall Survival (5-Year OS)
Time frame: 5 Years
Number of Participants With Unacceptable Toxicity.
Time frame: Up to 12 weeks post-therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25315074Lossos IS, Fabregas JC, Koru-Sengul T, Miao F, Goodman D, Serafini AN, Hosein PJ, Stefanovic A, Rosenblatt JD, Hoffman JE. Phase II study of (90)Y Ibritumomab tiuxetan (Zevalin) in patients with previously untreated marginal zone lymphoma. Leuk Lymphoma. 2015 Jun;56(6):1750-5. doi: 10.3109/10428194.2014.975801. Epub 2014 Nov 20.
Related trials for Marginal Zone Lymphoma
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Active, not recruitingPhase 2
PET/CT-Guided Maintenance Therapy in Previously Untreated MZL
Marginal Zone Lymphoma(MZL)
Active, not recruitingPhase 1/2
First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
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Active, not recruitingPhase 1/2
Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (R/R B-NHL)
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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.
Izidore S. Lossos, MD study chair
University of Miami Sylvester Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab and Ibritumomab Tiuxetan in people with Marginal Zone Lymphoma, run by University of Miami 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 7 inclusion and 8 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 1 Jan 2016. 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 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?
Yes. Results are posted in the registry (first posted 1 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy. (time frame: 12 weeks post-therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00453102, which also lists 1 linked publication.
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 Jan 2016.