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

• 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 two unexpanded cord blood units. (Biological): Umbilical Cord Blood.

Primary outcomes

• Time to Neutrophil and Platelet Engraftment [100 days]

Secondary outcomes

• 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 outcomes

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

Sex: All, ages: any to 65 Years

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

• Donna Skerrett, MD, MS, Study director, Mesoblast, Ltd.
• Elizabeth J. Shpall, MD, Principal investigator, M.D. Anderson Cancer Center