ibritumomab tiuxetan
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Zevalin | — | 2024-01-04 | europa.eu ↗ |
| Label expansions (4) | US (FDA) | ZEVALIN | — | 2004-10-22 – 2011-11-18 | fda.gov ↗ |
| Approved | EU (EMA) | Zevalin | — | 2004-01-16 | europa.eu ↗ |
| Approved | US (FDA) | ZEVALIN | — | 2002-02-19 | fda.gov ↗ |
Trials 47 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00186589 | May 2004 → Jul 2007 | non-Hodgkin lymphoma | Stanford University | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT00807196 | Sep 2008 → Dec 2011 | non-Hodgkin lymphoma | Maisonneuve-Rosemont Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT00372905 | Jul 2007 → Jun 2010 | lymphoma | Northwestern University | Terminated | No outcome recorded |
| Phase 1/2 | NCT00302757 | Mar 2006 → Jul 2011 | non-Hodgkin lymphoma | University Hospital Tuebingen | Completed | No outcome recorded |
| Phase 1/2 | NCT00089284 | Oct 2003 → Jan 2007 | non-Hodgkin lymphoma | Northwestern University | Terminated | No outcome recorded |
| Phase 1/2 | NCT00048737 | Oct 2002 → Dec 2011 | leukemia, lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 229 trials | ||||||
| Phase 2 | NCT01811368 | Mar 2013 → Apr 2023 | non-Hodgkin lymphoma | Joseph Tuscano | Unknown | No outcome recorded |
| Phase 2 | NCT01497275 | Feb 2012 → May 2014 | mantle cell lymphoma | Duke University | Terminated | No outcome recorded |
| Phase 2 | NCT00662948 | Dec 2008 → Oct 2014 | lymphoma | PETHEMA Foundation | Completed | No outcome recorded |
| Phase 2 | NCT00722930 | Apr 2008 → Apr 2011 | follicular lymphoma | Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas | Unknown | No outcome recorded |
| Phase 2 | NCT00607854 | Feb 2008 → Feb 2011 | diffuse large B-cell lymphoma, mantle cell lymphoma | University Hospital, Bordeaux | Completed | No outcome recorded |
| Phase 2 | NCT00644371 | Nov 2007 → Feb 2011 | non-Hodgkin lymphoma | Spanish Lymphoma Cooperative Group | Completed | No outcome recorded |
| Phase 2 | NCT00772655 | Oct 2007 → Jun 2010 | follicular lymphoma | Charite University, Berlin, Germany | Unknown | No outcome recorded |
| Phase 2 | NCT00689169 | Aug 2007 → Jan 2011 | diffuse large B-cell lymphoma | Lymphoma Study Association | Completed | No outcome recorded |
| Phase 2 | NCT01157988 | Jan 2007 → Jan 2009 | diffuse large B-cell lymphoma | Chonnam National University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00440583 | Sep 2006 → Sep 2011 | diffuse large B-cell lymphoma | Mahidol University | Completed | No outcome recorded |
| Phase 2 | NCT00493467 | Jun 2006 → Apr 2015 | lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00386321 | Apr 2006 → Jul 2007 | diffuse large B-cell lymphoma | Chulalongkorn University | Terminated | No outcome recorded |
| Phase 2 | NCT00493454 | Apr 2006 → Mar 2011 | lymphoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT00521560 | Mar 2006 → Aug 2009 | aggressive B-cell non-Hodgkin lymphoma | Institute of Application-oriented Research and Clinical Trials GmbH | Completed | No outcome recorded |
| Phase 2 | NCT00453102 | Feb 2006 → Feb 2015 | marginal zone lymphoma | University of Miami | Completed | No outcome recorded |
| Phase 2 | NCT00505232 | Jan 2006 → Mar 2010 | mantle cell lymphoma | CABYC | Completed | No outcome recorded |
| Phase 2 | NCT00354822 | Aug 2005 → Aug 2009 | non-Hodgkin lymphoma | A.O. Ospedale Papa Giovanni XXIII | Terminated | No outcome recorded |
| Phase 2 | NCT00138086 | Mar 2005 → Mar 2009 | indolent B-cell non-Hodgkin lymphoma | Lymphoma Study Association | Completed | No outcome recorded |
| Phase 2 | NCT00119730 | Feb 2005 → Dec 2006 | mantle cell lymphoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT00582166 | Jan 2005 → Mar 2013 | non-Hodgkin lymphoma | University of Wisconsin, Madison | Terminated | No outcome recorded |
| Phase 2 | NCT00220285 | Aug 2004 → Oct 2005 | B-cell non-Hodgkin lymphoma | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT00290511 | Jun 2004 → Feb 2021 | lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00070447 | Nov 2003 → Jun 2006 | lymphoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT00177554 | Nov 2003 → May 2007 | non-Hodgkin lymphoma | University of Pittsburgh | Completed | No outcome recorded |
| Phase 2 | NCT00038623 | Apr 2002 → Dec 2007 | mantle cell lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00193440 | Apr 2002 → Apr 2004 | non-Hodgkin lymphoma | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 2 | NCT00005592 | Nov 1999 → Mar 2002 | lymphoma | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 2 | NCT00850512 | — | diffuse large B-cell lymphoma | University of Bologna | Completed | No outcome recorded |
| Phase 2 | NCT00859001 | — | follicular lymphoma | University of Bologna | Completed | No outcome recorded |
| Phase 310 trials | ||||||
| Phase 3 | NCT01662102 | Dec 2012 → Mar 2013 | follicular lymphoma | Spectrum Pharmaceuticals, Inc | Terminated | No outcome recorded |
| Phase 3 | NCT02063685 | Jul 2012 → Dec 2021 | follicular lymphoma | Fondazione Italiana Linfomi - ETS | Completed | No outcome recorded |
| Phase 3 | NCT01510184 | Apr 2012 → Oct 2014 | diffuse large B-cell lymphoma, follicular lymphoma | Spectrum Pharmaceuticals, Inc | Terminated | No outcome recorded |
| Phase 3 | NCT00491491 | Jun 2007 → Feb 2015 | non-Hodgkin lymphoma | Sheba Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT00463463 | Apr 2007 → ? | non-Hodgkin lymphoma | Soroka University Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT00384111 | Oct 2006 → Nov 2008 | follicular lymphoma | Spectrum Pharmaceuticals, Inc | Terminated | No outcome recorded |
| Phase 3 | NCT00322218 | May 2006 → Dec 2008 | diffuse large B-cell lymphoma | Spectrum Pharmaceuticals, Inc | Terminated | No outcome recorded |
| Phase 3 | NCT00319332 | Sep 2005 → Feb 2021 | follicular lymphoma | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 3 | NCT00057343 | Mar 2003 → ? | non-Hodgkin lymphoma | Biogen | Terminated | No outcome recorded |
| Phase 3 | NCT00185393 | Aug 2001 → Feb 2007 | non-Hodgkin lymphoma | Bayer | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00168727 | Jun 2003 → Oct 2005 | non-Hodgkin lymphoma | Biogen | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00387023 | Feb 2004 → Jul 2012 | non-Hodgkin lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00392691 Background | Oct 2006 → Dec 2012 | lymphoma | Swiss Cancer Institute | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04189588 Comparator | Mar → Nov 2020 | — | TerSera Therapeutics LLC | Completed | No outcome recorded |
| Phase 2 | NCT00591630 Comparator | Nov 2007 → Mar 2020 | diffuse large B-cell lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 54 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ibritumomab -tiuxetan | “A Phase 3 Open Label Multicenter, Randomized Study to Compare the Efficacy and Safety of the Zevalin (Ibritumomab Tiuxetan) Therapeutic Regimen Following Cyclophosphamide,...” NCT00384111 ↗38“Yttrium-90 (90Y) ibritumomab tiuxetan 0.4 mCi/kg is delivered to patient achieving at least a partial remission (PR) after chemotherapy as a single dose for patients with...” NCT00354822 ↗ “short-course chemoimmunotherapy with cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (CHOP-R) followed by 90-Y ibritumomab tiuxetan (RIT) with extended...” PMID 18981007 ↗ Nov 2008 “We therefore subsequently performed a trial in which (90)Y-ibritumomab tiuxetan (0.4 mCi/kg) was added to the fludarabine, cyclophosphamide conditioning regimen ((90)YFC).” PMID 22586182 ↗ May 2012 “Ibritumomab tiuxetan ("Zevalin) is composed of a murine IgG1 monoclonal antibody (ibritumomab) covalently bound to the chelating agent tiuxetan.” NCT00850512 ↗ “patients receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8; yttrium Y 90 Zevalin®) IV over 10 minutes on day 8.” NCT00070447 ↗ “Ibritumomab tiuxetan (another similar monoclonal antibody, which delivers radiation to the lymphoma cells to strengthen the attack).” NCT00290511 ↗ “Ibritumomab tiuxetan is an antibody targeted against CD20, which carries a radioactive material called 90-Yttrium.” NCT00038623 ↗ “After rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1.” NCT00089284 ↗ “radioimmunotherapy (RIT) using yttrium-90-ibritumomab tiuxetan at two dose levels (22 and 30 MBq/kg)” PMID 22504934 ↗ Apr 2012 “one \[90Y\]-ibritumomab tiuxetan infusion in connection with the second rituximab infusion” NCT00322218 ↗ “Standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy (RIT)” NCT00689169 ↗ “Ibritumomab -tiuxetan (Zevalin)” NCT00505232 ↗ |
| Known as | 90-yttrium-ibritumomab tiuxetan | “Radioimmunotherapy with 90-yttrium-ibritumomab tiuxetan (90Y-IT) as first-line treatment in patients with follicular lymphoma (FL) demonstrated promising results with a...” PMID 35150296 ↗ Feb 20221“This is a European multicenter study of 90Yttrium-Ibritumomab Tiuxetan (90Y-Ibritumomab Tiuxetan) (Zevalin®) as a front line therapy for patients with follicular lymphoma grade...” NCT00772655 ↗ |
| Known as | 90Y Zevalin | “On day 8, within 4 hours following completion of the rituximab dose, 90Y Zevalin at a dose of 0.4 mCi/kg actual body weight” NCT01157988 ↗ |
| Known as | 90Y-ibritumomab tiuxetan | “A single course of 90Y-Ibritumomab Tiuxetan (according to the standard procedure that includes Rituximab 250 mg/m2 plus 111In-Ibritumomab Tiuxetan for dosimetry on day one...” NCT00772655 ↗5“The clinical efficacy and safety of yttrium-90 ((90)Y)-ibritumomab tiuxetan consolidation treatment following rituximab” PMID 22035417 ↗ Dec 2011 “Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg” NCT00662948 ↗ “90Y-ibritumomab tiuxetan Consolidation After 6th R-CHOP Chemotherapy” NCT01157988 ↗ “a single course of IDEC-Y2B8 (90Y-ibritumomab tiuxetan, Zevalin)” NCT00186589 ↗ “Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128)” NCT00185393 ↗ |
| Known as | 90Y-IT | “Radioimmunotherapy with 90-yttrium-ibritumomab tiuxetan (90Y-IT) as first-line treatment in patients with follicular lymphoma (FL) demonstrated promising results with a...” PMID 35150296 ↗ Feb 2022 |
| Known as | BAY86-5128 | “Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128)” NCT00185393 ↗1“Zevalin (SH L 749 , BAY86-5128)” NCT00220285 ↗ |
| Known as | IDEC-Y2B8 | “patients receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8; yttrium Y 90 Zevalin®) IV over 10 minutes on day 8.” NCT00070447 ↗2“IDEC-Y2B8 is a mouse monoclonal antibody with small particles of radioactivity that join to the CD20 antigens on lymphoma cells.” NCT00005592 ↗ “a single course of IDEC-Y2B8 (90Y-ibritumomab tiuxetan, Zevalin)” NCT00186589 ↗ |
| Known as | SH L 749 | “Zevalin (SH L 749 , BAY86-5128)” NCT00220285 ↗ |
| Known as | Y90-Ibritumomab -Tiuxetan | “We designed a phase II clinical trial including Y-90 ibritumomab-tiuxetan as part of a reduced-intensity conditioning (RIC) allogeneic stem cell transplantation (AlloSCT) in...” PMID 27771496 ↗ Oct 20161“Y90-Ibritumomab -Tiuxetan (Zevalin)” NCT00505232 ↗ |
| Known as | Yt90-ibritumomab tiuxetan | “Ibritumomab is covalently linked to the tiuxetan chelate and radiolabeled with Yt90, producing Yt90-ibritumomab tiuxetan (Yt90-Zevalin).” NCT00440583 ↗ |
| Known as | Yt90-Zevalin | “Ibritumomab is covalently linked to the tiuxetan chelate and radiolabeled with Yt90, producing Yt90-ibritumomab tiuxetan (Yt90-Zevalin).” NCT00440583 ↗ |
| Known as | yttrium Y 90 ibritumomab tiuxetan | “patients receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8; yttrium Y 90 Zevalin®) IV over 10 minutes on day 8.” NCT00070447 ↗ |
| Known as | yttrium Y 90 Zevalin | “patients receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8; yttrium Y 90 Zevalin®) IV over 10 minutes on day 8.” NCT00070447 ↗ |
| Known as | yttrium-90 ibritumomab tiuxetan | “Pilot trial of yttrium-90 ibritumomab tiuxetan consolidation following” PMID 22035417 ↗ Dec 2011 |
| Known as | Zevalin | “Ibritumomab tiuxetan ("Zevalin) is composed of a murine IgG1 monoclonal antibody (ibritumomab) covalently bound to the chelating agent tiuxetan.” NCT00850512 ↗27“Ibritumomab tiuxetan (Zevalin) is composed of a murine IgG1 monoclonal antibody (ibritumomab) covalently bound to the chelating agent tiuxetan.” NCT00859001 ↗ “followed by ibritumomab tiuxetan (Zevalin) consolidation in patients with limited-stage, bulky diffuse large B cell lymphoma” NCT01157988 ↗ “2. Ibritumomab tiuxetan (Zevalin): 0.4 mCi/kg (14.8 MBq/kg). Maximum: 32 mCi on day -14.” NCT00644371 ↗ “Ibritumomab Tiuxetan(Zevalin): 0.4 mCi/kg IV at day -14 (Day 0 is the transplantation)” NCT00607854 ↗ “Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg” NCT00662948 ↗ “standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) radioimmunotherapy” NCT00689169 ↗ “a single course of IDEC-Y2B8 (90Y-ibritumomab tiuxetan, Zevalin)” NCT00186589 ↗ “with 90Y-ibritumomab tiuxetan (Zevalin®) in patients” NCT00722930 ↗ “Yttrium 90 -labeled ibritumomab tiuxetan (Zevalin)” NCT00386321 ↗ “Ibritumomab Tiuxetan (Zevalin) + Rituximab” NCT00582166 ↗ “90Y ibritumomab tiuxetan (Zevalin)” NCT00807196 ↗ “Ibritumomab Tiuxetan (Zevalin®)” NCT00453102 ↗ “Ibritumomab -tiuxetan (Zevalin)” NCT00505232 ↗ “ibritumomab tiuxetan (Zevalin®)” NCT00168727 ↗ “Zevalin (ibritumomab tiuxetan)” NCT00057343 ↗ “Zevalin” NCT04189588 ↗ |
| Action | Deplete | “It is used to deliver radiation therapy to kill lymphoma cells.” NCT00005592 ↗ |
| Modality | Monoclonal antibody | “90Y Zevalin and 111In Zevalin are murine-based antibodies combined with a radioactive agent that can also destroy lymphoma cells.” NCT00048737 ↗ |
| Route | Intravenous | “This is a one time intravenous infusion for eligible patients” NCT00005592 ↗ |