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Zevalin

Phase 3

Lymphoma, Non-Hodgkin | Monoclonal antibody | Oncology |Bayer AG|Last Updated: Dec 30, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment414

FDA Designations

No designations recorded

Clinical trial landscape

Zevalin · 2 trials · 4 indications

Phase 3 1Phase 2 1
NCT00185393Treatment With [90]Y-Ibritumomab Tiuxetan Versus no Treatment in Patients With Follicular Non Hodgkin Lymphoma (Stage III or IV) Having Achieved a Partial or Complete Remission After First Line ChemotherapyLymphoma, Non-Hodgkin
COMPLETED414 Analytics
PHASE3COMPLETED
Treatment With [90]Y-Ibritumomab Tiuxetan Versus no Treatment in Patients With Follicular Non Hodgkin Lymphoma (Stage III or IV) Having Achieved a Partial or Complete Remission After First Line Chemotherapy
Lymphoma, Non-Hodgkin
NCT00185393414
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Study Endpoints

Primary Endpoints

Progression free survival
End of study
Best overall response rates (the percentage of patients who achieved PR or better response)
After 9 weeks or 13 weeks
The incidence of critical toxicity
During treatment period

Secondary Endpoints

Clinical and molecular response rates
End of study
Overall survival
End of study
Quality of Life
End of study
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2OTHER -

Interventions

NameTypeDescription
Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128)BIOLOGICALtreatment with 90 Yttrium-labeled anti CD 20 antibody
no treatmentOTHERno treatment
Zevalin (SH L 749 , BAY86-5128)DRUG0,3mCi/kg
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites95

Inclusion Criteria: * Non Hodgkin Lymphoma stage III or IV at timepoint of diagnosis * Patients who have achieved a remission after first line chemotherapy * No less than 6 weeks and no more than 12 weeks since last dose of chemotherapy * older than 18 years * written informed consent Exclusion Cr...

Countries:BelgiumCanadaDenmarkFranceGermanyItalyNetherlandsNorwayPortugalSpainSwedenSwitzerlandUnited KingdomJapan
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Frequently asked questions about Zevalin

What is Zevalin used for in Non-Hodgkin's Lymphoma?

Zevalin is a monoclonal antibody used for the treatment of Non-Hodgkin's Lymphoma, including follicular lymphoma. It is being developed by Bayer AG (ticker: BAYRY) and is currently in Phase 3 clinical development for this indication.

What does Zevalin target?

Zevalin is a monoclonal antibody that targets CD20, a protein found on the surface of B-cells. By binding to CD20, it helps direct radiation to cancerous B-cells in Non-Hodgkin's Lymphoma, potentially destroying them.

Who makes Zevalin?

Zevalin is developed by Bayer AG, a pharmaceutical company traded under the ticker BAYRY. The drug is being studied for the treatment of Non-Hodgkin's Lymphoma and is currently in Phase 3 clinical trials.

What phase is Zevalin in?

Zevalin is in Phase 3 clinical development for Non-Hodgkin's Lymphoma. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and efficacy.

What clinical trials is Zevalin in?

Zevalin has been studied in two completed clinical trials. NCT00185393 was a Phase 3 trial with 414 participants evaluating treatment with 90Y-Ibritumomab Tiuxetan versus no treatment in follicular Non-Hodgkin Lymphoma. NCT00220285 was a Phase 2 trial with 45 participants in Japan.

Is Zevalin the same as 90Y-Ibritumomab Tiuxetan?

Yes, Zevalin is also known as 90Y-Ibritumomab Tiuxetan. In clinical trials, this name is used to describe the drug, which is a radiolabeled monoclonal antibody being studied for the treatment of Non-Hodgkin's Lymphoma.