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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01854567
Other study ID # CB-AB006
Secondary ID 2012-0166
Status Completed
Phase Phase 3
First received
Last updated
Start date August 2013
Est. completion date May 5, 2017

Study information

Verified date June 2020
Source Mesoblast, Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study investigates the time to engraftment of a mesenchymal expanded cord blood unit in patients with hematologic malignancies undergoing transplantation with myeloablative conditioning.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date May 5, 2017
Est. primary completion date September 23, 2016
Accepts healthy volunteers No
Gender All
Age group N/A to 65 Years
Eligibility 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 remission at study screening (Complete Remission with Incomplete Platelet Recovery (CRp) acceptable).

- Non-Hodgkin's lymphoma (NHL): High risk subjects with responsive disease after first relapse. High risk includes those with Burkitt's Lymphoma and those with extensive marrow involvement at diagnosis-precluding autologous transplant.

- Hodgkin's disease: High risk subjects with responsive disease after first relapse.

- Minimum Karnofsky Scale

- Subject must weigh at least 20 kg

- Up to 65 years of age

- Adequate major organ system function

Exclusion Criteria:

- Pregnancy and/or lactating

- Suitable, 6/6 HLA matched related sibling donor available

- Previous participation in a stem cell study within last 30 days

Study Design


Intervention

Biological:
Infusion of one MPC expanded cord unit and one unexpanded cord unit
Infusion of one MPC expanded cord unit and one unexpanded cord unit.
Infusion of two unexpanded cord blood units.
Umbilical Cord Blood.

Locations

Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Case Western Cleveland Ohio
United States MD Anderson Cancer Center Houston Texas
United States University of Miami Health System Sylvester Comprehensive Cancer Center Miami Florida
United States Memorial Sloan Kettering Cancer Center New York New York
United States Weill Cornell-New York Presbyterian Hospital New York New York
United States Texas Transplant Center at Methodist Healthcare System San Antonio Texas
United States Moffitt Cancer Center Tampa Florida
United States Westchester Medical Center Valhalla New York

Sponsors (1)

Lead Sponsor Collaborator
Mesoblast, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Incidence and severity of acute Graft Versus Host Disease 100 days
Primary Time to Neutrophil and Platelet Engraftment 100 days
Secondary Proportion of subjects with neutrophil recovery at day 26, platelet recovery at day 60 and subjects alive at day 100 100 days
Secondary Percentage of patients with primary graft failure 100 days
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