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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 23, 2016

Interventions

  • 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.
  • Biological: Infusion of two unexpanded cord blood units.
    • Umbilical Cord Blood.

Arms, Groups and Cohorts

  • Experimental: Active
    • Infusion of one MPC expanded cord unit and one unexpanded cord unit.
  • Active Comparator: Control
    • Infusion of two unexpanded cord blood units.

Clinical Trial Outcome Measures

Primary Measures

  • Time to Neutrophil and Platelet Engraftment
    • Time Frame: 100 days

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mesoblast, Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Donna Skerrett, MD, MS, Study Director, Mesoblast, Ltd.
    • Elizabeth J. Shpall, MD, Principal Investigator, M.D. Anderson Cancer Center

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