Overview

This trial is active, not recruiting.

Conditions acute myelogenous leukemia, acute lymphoblastic leukemia, non-hodgkin's lymphoma, hodgkin's disease
Treatments infusion of one mpc expanded cord unit and one unexpanded cord unit, infusion of two unexpanded cord blood units.
Phase phase 3
Sponsor Mesoblast, Ltd.
Start date February 2013
End date February 2018
Trial size 240 participants
Trial identifier NCT01854567, 2012-0166, CB-AB006

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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 one MPC expanded cord unit and one unexpanded cord unit.
(Active Comparator)
Infusion of two unexpanded cord blood units.
infusion of two unexpanded cord blood units.
Umbilical Cord Blood.

Primary Outcomes

Measure
Time to Neutrophil and Platelet Engraftment
time frame: 100 days

Secondary Outcomes

Measure
Proportion of subjects with neutrophil recovery at day 26, platelet recovery at day 60 and subjects alive at day 100
time frame: 100 days
Percentage of patients with primary graft failure
time frame: 100 days

Eligibility Criteria

Male or female participants up to 65 years old.

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

Additional Information

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
Principal investigator Elizabeth J. Shpall, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Mesoblast, Ltd..
Location data was received from the National Cancer Institute and was last updated in July 2016.