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90Y-ibritumomab

Phase 1/2

B-cell Lymphoma | Monoclonal antibody | Other |Bayer AG|Trials Updated: Feb 19, 2016

90Y-ibritumomab development status

Highest phase Phase 1/2 (NCT00761384)
Phase scored for BAYRYPhase 1
Registered trials 1 across 1 sponsor since Sep 2008

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

90Y-ibritumomab clinical trials

90Y-ibritumomab · 1 trial · 1 indication

Phase 1/2 1
NCT00761384High Dose, Absorbed Dose Adjusted 90Y-ibritumomab With Peripheral Blood Stem Cells (PBSC) Support in B-cell LymphomaB-cell Lymphoma
COMPLETED7 Analytics
PHASE1/PHASE2COMPLETED
High Dose, Absorbed Dose Adjusted 90Y-ibritumomab With Peripheral Blood Stem Cells (PBSC) Support in B-cell Lymphoma
B-cell Lymphoma
NCT007613847
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Study Endpoints

Primary Endpoints

Maximal tolerable dose (MTD) absorbed dose to the liver, safety and time to treatment failure (TTF)
5 years

Secondary Endpoints

Overall response (OR), complete response (CR), their duration, absorbed dose to normal organ and tumours, relapse pattern, the effect of radioimmunotherapy (RIT) in its own right as assessed by positron emission tomography (PET)
5 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
90Y-ibritumomabEXPERIMENTAL90Y-ibritumomab given with stem cells support, based on absorbed dose escalation to the liver. Absorbed dose escalation starts at 12 Gy and is capped at 36 Gy to the liver.

Interventions

NameTypeDescription
90Y-ibritumomabDRUG90Y-ibritumomab given with stem cells support, based on absorbed dose escalation to the liver. Absorbed dose escalation starts at 12 Gy and is capped at 36 Gy to the liver.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Written informed concent * Age at least 18 years * WHO Performance status 0-3 * Histologically verified B-cell lymphoma * Diffuse large B-cell lymphoma and follicular grade III, failing an anthracycline containing regimen and patients not found suitable for a second line chemo...

Countries:Sweden
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Competitive Landscape -Cutaneous T-Cell Lymphoma 8 trials (matched to "B-cell Lymphoma")

Top 1 of 2 competitors

CompanyTickerTrialsLead PhaseDrugs
Incyte CorporationINCY1PHASE2Ruxolitinib
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