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90-Y-ibritumomab tiuxetan

Phase 2

Lymphoma | Monoclonal antibody | Oncology |Biogen Inc.|Last Updated: Oct 21, 2015

Success Probability

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment23

FDA Designations

No designations recorded

Clinical trial landscape

90-Y-ibritumomab tiuxetan · 1 trial · 1 indication

Phase 2 1
NCT00005592Radioimmunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's LymphomaLymphoma
COMPLETED23 Analytics
PHASE2COMPLETED
Radioimmunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

To provide treatment to those patients with low-grade follicular or transformed B-cell non-Hodgkin's lymphoma who are not eligible for other IDEC-Y2B8 protocols.
up to 4.25 years

Secondary Endpoints

To add to the overall efficacy and safety experience in this indication.
up to 4.25 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Rituxan + IDEC-In2B8, Rituxan + IDEC-Y2B8EXPERIMENTALFor the first treatment, 250 mg/m2 Rituxan infusion and injection of IDEC-In2B8 (Indium- radioactive label) is given. If therapy is continued, approximately 1 week later a second infusion of Rituximab (250 mg/m2) is given followed by an infusion of IDEC-Y2B8 (Yttrium-radioactive label).

Interventions

NameTypeDescription
90-Y-ibritumomab tiuxetanBIOLOGICALIDEC-Y2B8 is a mouse monoclonal antibody with small particles of radioactivity that join to the CD20 antigens on lymphoma cells. It is used to deliver radiation therapy to kill lymphoma cells. This is a one time intravenous infusion for eligible patients and is given over a ten-minute time period.
rituximabBIOLOGICALRituxan is a mouse/human monoclonal antibody and reacts with the CD20 antigens found on lymphoma cells and causes the body's immune system to destroy the lymphoma cells. It is infused at a dose of 250 mg/m2 followed by a second infusion approximately one week later of the same dose.
indium In 111 ibritumomab tiuxetanRADIATIONIDEC-In2B8 is a mouse monoclonal antibody that contains Indium, routinely used in nuclear medicine. It is given as a one-time intravenous injection over a ten-minute time period immediately following a Rituxan infusion. The physician will then be able to see and evaluate the location and concentration of the antibody in the body.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

DISEASE CHARACTERISTICS: Histologically proven relapsed or refractory, low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma (NHL) Prior rituximab allowed if no response achieved CD20-positive B-cells in lymph nodes or bone marrow required for small lymphocytic or transformed NHL Less ...

Countries:United States
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Competitive Landscape -Lymphoma 338 trials

Top 20 of 66 competitors

CompanyTickerTrialsLead PhaseDrugs
Regeneron Pharmaceuticals, Inc.REGN7PHASE3Odronextamab, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine
Eli Lilly and CompanyLLY12PHASE3Pirtobrutinib, Idelalisib, Bendamustine, Rituximab
AstraZeneca PLCAZN14PHASE3Surovatamig, R-CHOP, R-CVP, BR
Merck & Co., Inc.MRK16PHASE3Nemtabrutinib, Fludarabine, Cyclophosphamide, Bendamustine, Rituximab
AbbVie, Inc.ABBV11PHASE3Venetoclax
Novartis AG Sponsored ADRNVS8PHASE3Tisagenlecleucel, Lenalidomide and rituximab in 28-day cycles for up to 12 cycles, Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone or prednisolone in 21-day cycles for 6 to 8 cycles, Lymphodepleting chemotherapy
Incyte CorporationINCY16PHASE3Tafasitamab, Lenalidomide
BeOne Medicines Ltd. Sponsored ADRONC20PHASE3BGB-16673, Bendamustine, Rituximab, Methylprednisolone, Chlorambucil
Gilead Sciences, Inc.GILD7PHASE3Axicabtagene Ciloleucel, Cyclophosphamide, Fludarabine, Lenalidomide, Rituximab
Genmab A/S Sponsored ADRGMAB18PHASE3Epcoritamab, Rituximab, Lenalidomide
Bristol-Myers Squibb CompanyBMY17PHASE3Golcadomide, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine
Johnson & JohnsonJNJ11PHASE3Ibrutinib
Pfizer Inc.PFE4PHASE3Brentuximab vedotin, Rituximab, Lenalidomide
Nurix Therapeutics, Inc.NRIX6PHASE3NX-5948, Pirtobrutinib
ADC Therapeutics LtdADCT4PHASE3Loncastuximab Tesirine, Rituximab, Gemcitabine, Oxaliplatin
Corvus Pharmaceuticals, Inc.CRVS2PHASE3Soquelitinib, Belinostat, Pralatrexate
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
HUTCHMED (China) Limited Sponsored ADRHCM2PHASE3HMPL-760, R-GemOx
Nuvalent, Inc. Class ANUVL1PHASE3Neladalkib, Alectinib
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK6PHASE2Brentuximab Vedotin, Cyclophosphamide, Doxorubicin, Prednisone
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Frequently asked questions about 90-Y-ibritumomab tiuxetan

What is 90-Y-ibritumomab tiuxetan used for?

90-Y-ibritumomab tiuxetan is used for the treatment of lymphoma, including non-Hodgkin's lymphoma. It is a monoclonal antibody being developed by Biogen Inc. for oncology indications. The drug is currently in clinical development and has been studied in patients with relapsed or refractory non-Hodgkin's lymphoma.

What does 90-Y-ibritumomab tiuxetan target?

90-Y-ibritumomab tiuxetan is a monoclonal antibody that targets CD20, a protein found on the surface of B-cells. By binding to CD20, the drug delivers a radioactive isotope, yttrium-90, directly to cancer cells, which helps to destroy them. This targeted approach is designed to treat lymphoma while minimizing damage to healthy cells.

Who makes 90-Y-ibritumomab tiuxetan?

90-Y-ibritumomab tiuxetan is developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. Biogen is responsible for the clinical development and manufacturing of this investigational monoclonal antibody for the treatment of lymphoma.

What phase is 90-Y-ibritumomab tiuxetan in?

90-Y-ibritumomab tiuxetan is in Phase 2 clinical development. It has completed one Phase 2 trial and one Phase 1 trial. The drug is investigational and has not been approved by the FDA. It is still being studied to evaluate its safety and efficacy in patients with lymphoma.

What clinical trials is 90-Y-ibritumomab tiuxetan in?

90-Y-ibritumomab tiuxetan has been studied in two completed clinical trials. NCT00005592 was a Phase 2 trial in patients with relapsed or refractory non-Hodgkin's lymphoma. NCT00186589 was a Phase 1 trial combining the drug with high-dose chemotherapy and autologous transplantation for relapsed or resistant non-Hodgkin's lymphoma.

Is 90-Y-ibritumomab tiuxetan the same as ibritumomab tiuxetan?

90-Y-ibritumomab tiuxetan is a radiolabeled form of ibritumomab tiuxetan, where the antibody is conjugated to the radioactive isotope yttrium-90. This form is specifically designed for radioimmunotherapy, delivering radiation directly to cancer cells. It is being studied for the treatment of lymphoma.