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

Acute Lymphoblastic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01854567
• Other study ID #: CB-AB006
• Secondary ID: 2012-0166
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myelogenous Leukemia
• Hematologic Neoplasms
• Hodgkin Disease
• Hodgkin's Disease
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Non-Hodgkin's Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

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