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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

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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 two unexpanded cord blood units · 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 LeukemiaUnlock trial analytics

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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Frequently asked questions about Infusion of two unexpanded cord blood units

What is Infusion of two unexpanded cord blood units used for?

Infusion of two unexpanded cord blood units is an investigational therapy being studied for use in patients with hematologic malignancies, including Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma, and Hodgkin's Disease. It is administered as part of a stem cell transplantation procedure.

Who makes Infusion of two unexpanded cord blood units?

Infusion of two unexpanded cord blood units is being developed by Mesoblast Limited, a biopharmaceutical company listed on the stock exchange under the ticker symbol MESO.

What phase is Infusion of two unexpanded cord blood units in?

Infusion of two unexpanded cord blood units is in Phase 3 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. One Phase 3 trial has been completed.

What clinical trials is Infusion of two unexpanded cord blood units in?

Infusion of two unexpanded cord blood units was studied in a completed Phase 3 clinical trial registered as NCT01854567. This trial evaluated the therapy in 49 patients with hematologic malignancies, including Acute Myelogenous Leukemia, and was conducted in the United States.

Is Infusion of two unexpanded cord blood units the same as expanded cord blood cells?

Infusion of two unexpanded cord blood units is distinct from expanded cord blood cells. The Phase 3 trial NCT01854567 studied umbilical cord blood cells expanded with mesenchymal precursor cells (MPCs) for transplantation, while the therapy name refers to the use of two unexpanded cord blood units.