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

Completed · Phase 3

Conditions studied: Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma, Hodgkin's Disease

In brief

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

Key facts

Study ID

NCT01854567

Run by

Mesoblast, Ltd.

People needed

49

Starts

2013-08-01

Expected to finish

2017-05-05

Last updated by the study team

2020-06-26

Who can join

Age: any, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Pregnancy and/or lactating
• Suitable, 6/6 HLA matched related sibling donor available
• Previous participation in a stem cell study within last 30 days

Where it is running

• University of Miami Health System Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, 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
• Westchester Medical Center — Valhalla, New York, United States
• Case Western — Cleveland, Ohio, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Texas Transplant Center at Methodist Healthcare System — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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