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Ibritumomab Tiuxetan

Phase 3FDA approved

Diffuse Large B-Cell Lymphoma | Monoclonal antibody | Other |Bayer AG|Last Updated: Oct 5, 2016

Development status

FDA approval on record Feb 19, 2002 as Zevalin
Approval holderSpectrum Pharms
ApplicationBLA125019
Highest phase Phase 3 run by GlaxoSmithKline (NCT00319332)
Phase scored for BAYRYPhase 2
Registered trials 3 across 3 sponsors since Apr 2006

Label indication Zevalin is a CD20-directed radiotherapeutic antibody administered as part of the Zevalin therapeutic regimen indicated for the treatment of adult patients with: relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL) ( 1.1 ). previously untreated follicular NHL who achieve a partial or complete response to first-line chemotherapy ( 1.2 ). FDA label

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

Ibritumomab Tiuxetan · 1 trial · 2 indications

Phase 2 1
NCT00607854Safety of Ibritumomab Tiuxetan (Zevalin®) in Combination With a Fludarabine-based Reduced Intensity Conditioning (RIC) Regimen (ZEVALLO 2007)Diffuse Large B-Cell Lymphoma
COMPLETED31 Analytics
PHASE2COMPLETED
Safety of Ibritumomab Tiuxetan (Zevalin®) in Combination With a Fludarabine-based Reduced Intensity Conditioning (RIC) Regimen (ZEVALLO 2007)
Diffuse Large B-Cell Lymphoma
NCT0060785431
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Study Endpoints

Primary Endpoints

the treatment-related mortality rate (except if the death is related to the lymphoma exclusively).
day 100 post transplant

Secondary Endpoints

The event-free-survival (EFS)(an event is defined as: death from any cause, relapse or progression, need to another treatment except for donor-lymphocytes injection (DLI), patient lost for follow-up)
1 year post transplant
The rate of hematologic recovery (defined as ANC above 500/mm3 and platelets count above 20.000/mm3 for three consecutive days without stimulating growth support neither platelet transfusion)
day 30
Biological post allogenic effects of Zevalin® on the incidence of GVHD and B-cell and T-cell reconstitution
days d0, d28, d90, d180 and 1 year
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ZevalinEXPERIMENTALZevalin associated with a Fludarabine-based reduced-intensity conditioning regimen,all patients will receive Zevalin in the conditioning regimen

Interventions

NameTypeDescription
Ibritumomab Tiuxetan (Zevalin)DRUGConditioning regimen followed by allogeneic hematopoietic stem cell transplantation. Ibritumomab Tiuxetan(Zevalin): 0.4 mCi/kg IV at day -14 (Day 0 is the transplantation)
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Age ≥ 18 and ≤ 65 * Patients with this lymphoma: 1. CD20 positive diffuse large B-cell lymphoma in relapse or refractory after two prior regimens or after one regimen including autologous stem cell transplantation, or 2. CD20 positive mantle-cell lymphoma in relapse or re...

Countries:France
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