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Infusion of two unexpanded cord blood units.

Phase 3

Acute Myelogenous Leukemia | Monoclonal antibody | Oncology |Mesoblast Limited|Last Updated: Jun 26, 2020

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
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment49
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01854567P3 Study of Umbilical Cord Blood Cells Expanded With MPCs for Transplantation in Patients With Hematologic MalignanciesPHASE3 COMPLETED 49Aug 1, 2013May 5, 2017Jun 26, 20209 United States
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Study Endpoints
Primary Endpoints
Time to Neutrophil and Platelet Engraftment
100 days
Secondary Endpoints
Proportion of subjects with neutrophil recovery at day 26, platelet recovery at day 60 and subjects alive at day 100
100 days
Percentage of patients with primary graft failure
100 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ActiveEXPERIMENTALInfusion of one MPC expanded cord unit and one unexpanded cord unit.
ControlACTIVE_COMPARATORInfusion of two unexpanded cord blood units.
Interventions
NameTypeDescription
Infusion of one MPC expanded cord unit and one unexpanded cord unitBIOLOGICALInfusion of one MPC expanded cord unit and one unexpanded cord unit.
Infusion of two unexpanded cord blood units.BIOLOGICALUmbilical Cord Blood.
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Eligibility Criteria
Age RangeN/A — 65 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Patient must have one of the following: * Acute myelogenous leukemia (AML) in complete morphological remission at study screening (Complete Remission with Incomplete Platelet Recovery (CRp) acceptable). * Acute lymphoblastic leukemia (ALL) in complete morphological remiss...

Countries:United States
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