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Infusion of one MPC expanded cord unit and one unexpanded cord unit

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment49

FDA Designations

No designations recorded

Clinical trial landscape

Infusion of one MPC expanded cord unit and one unexpanded cord unit · 1 trial · 4 indications

Phase 3 1
NCT01854567P3 Study of Umbilical Cord Blood Cells Expanded With MPCs for Transplantation in Patients With Hematologic MalignanciesAcute Myelogenous Leukemia
COMPLETED49 Analytics
PHASE3COMPLETED
P3 Study of Umbilical Cord Blood Cells Expanded With MPCs for Transplantation in Patients With Hematologic Malignancies
Acute Myelogenous Leukemia
NCT0185456749
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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 to 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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