P3 Study of Umbilical Cord Blood Cells Expanded With MPCs for Transplantation in Patients With Hematologic Malignancies

Sponsor

Mesoblast, Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT01854567

Collaborator

(none)

Enrollment

Locations

Arms

45.1

Actual Duration (Months)

5.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia Non-Hodgkin's Lymphoma Hodgkin's Disease	Biological: Infusion of one MPC expanded cord unit and one unexpanded cord unit Biological: Infusion of two unexpanded cord blood units.	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A 1-Year, Multicenter, Randomized, Open-Label Controlled Study to Evaluate the Efficacy and Safety of Cord Blood Cells Expanded With MPCs for Hematopoetic Recovery in Patients With Hematologic Malignancies After Myeloablative Treatment

Actual Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Sep 23, 2016

Actual Study Completion Date :

May 5, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active Infusion of one MPC expanded cord unit and one unexpanded cord unit.	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.
Active Comparator: Control Infusion of two unexpanded cord blood units.	Biological: Infusion of two unexpanded cord blood units. Umbilical Cord Blood.

Arm

Intervention/Treatment

Experimental: Active

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

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.

Active Comparator: Control

Infusion of two unexpanded cord blood units.

Biological: Infusion of two unexpanded cord blood units.

Umbilical Cord Blood.

Outcome Measures

Primary Outcome Measures

Time to Neutrophil and Platelet Engraftment [100 days]

Secondary Outcome Measures

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]

Other Outcome Measures

Incidence and severity of acute Graft Versus Host Disease [100 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami Health System Sylvester Comprehensive Cancer Center	Miami	Florida	United States	33136
2	Moffitt Cancer Center	Tampa	Florida	United States	33612
3	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
4	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
5	Weill Cornell-New York Presbyterian Hospital	New York	New York	United States	10065
6	Westchester Medical Center	Valhalla	New York	United States	10595
7	Case Western	Cleveland	Ohio	United States	44106
8	MD Anderson Cancer Center	Houston	Texas	United States	77030
9	Texas Transplant Center at Methodist Healthcare System	San Antonio	Texas	United States	78229