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

Status:	Completed
Conditions:	Blood Cancer, Lymphoma, Hematology
Therapuetic Areas:	Hematology, Oncology
Healthy:	No
Age Range:	Any - 65
Updated:	9/20/2018
Start Date:	August 2013
End Date:	May 5, 2017

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

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

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

We found this trial at

sites

Beth Israel Deaconess Medical Center

330 Brookline Ave
Boston, Massachusetts 02215

617-667-7000