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R-CHOEP14x6+HD-AraC+HD-Mtx

Phase 2

Diffuse Large B-Cell Lymphoma | Small molecule | Oncology |Amgen Inc.|Last Updated: Sep 30, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment160
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01502982Dose Dense Chemotherapy and Rituximab for Young High Risk Diffuse Large B-Cell Lymphoma Patients (CRY-04)PHASE2 COMPLETED 160Nov 1, 2004May 1, 2014Sep 30, 20144 Denmark, Finland +2
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Study Endpoints
Primary Endpoints
Time to treatment failure
5 years

Interval between the registration date and the date of documented progression or lack of response, first relapse, death for any reason or discontinuation/change of therapy because of toxicity, whichever occurs first. Otherwise, patients will be censored at the last date they were known to be alive. For patients not responding at any time point on study treatment, TTF is defined as 1 day.

Secondary Endpoints
Number of participants with adverse events
Treatment period (5 years)
Clinical response rate
Treatment period (5 years)
Time to progression
5 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ChemoimmunotherapyEXPERIMENTAL -
Interventions
NameTypeDescription
R-CHOEP14x6+HD-AraC+HD-MtxDRUGrituximab 375 mg/m2 day 1 cyclophosphamide 750 mg/m2 day 1 doxorubicin 50 mg/m2 day 1 vincristine 1.4 mg/m2 day 1 etoposide 100mg/m2 days 1,2,3 Prednison 100 mg days 1,2,3,4,5 cycle repeated six times every two weeks followed by HD-AraC 3g/m2x4 and HD-mtx 3 g/m2 HD-AraC 3g/m2x4 times every 12 h
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Age ≥ 18 - \< 65 years. 2. Histology verified according to the WHO classification and with CD20 positivity by immunhistochemistry or flow cytometry: * Diffuse large B-cell lymphomas with subgroups except posttransplantation-, Burkitt-like- and primary CNS lymphomas and ca...

Countries:DenmarkFinlandNorwaySweden
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