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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Mesoblast, Ltd.
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd.
ClinicalTrials.gov Identifier:
NCT01854567
First received: May 13, 2013
Last updated: November 25, 2014
Last verified: November 2014

May 13, 2013
November 25, 2014
February 2013
February 2018   (final data collection date for primary outcome measure)
Time to Neutrophil and Platelet Engraftment [ Time Frame: 100 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01854567 on ClinicalTrials.gov Archive Site
  • Proportion of subjects with neutrophil recovery at day 26, platelet recovery at day 60 and subjects alive at day 100 [ Time Frame: 100 days ] [ Designated as safety issue: No ]
  • Percentage of patients with primary graft failure [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
Same as current
Incidence and severity of acute Graft Versus Host Disease [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
Same as current
 
P3 Study of Umbilical Cord Blood Cells Expanded With MPCs for Transplantation in Patients With Hematologic Malignancies
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Myelogenous Leukemia
  • Acute Lymphoblastic Leukemia
  • Non-Hodgkin's Lymphoma
  • Hodgkin's Disease
  • 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.
  • Experimental: Active
    Infusion of one MPC expanded cord unit and one unexpanded cord unit.
    Intervention: Biological: Infusion of one MPC expanded cord unit and one unexpanded cord unit
  • Active Comparator: Control
    Infusion of two unexpanded cord blood units.
    Intervention: Biological: Infusion of two unexpanded cord blood units.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
July 2018
February 2018   (final data collection date for primary outcome measure)

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
Both
up to 65 Years
No
Contact: Rebecca Cohen rebecca.cohen@mesoblast.com
United States
 
NCT01854567
CB-AB006, 2012-0166
Yes
Mesoblast, Ltd.
Mesoblast, Ltd.
Not Provided
Study Director: Donna Skerrett, MD, MS Mesoblast, Ltd.
Principal Investigator: Elizabeth J. Shpall, MD M.D. Anderson Cancer Center
Mesoblast, Ltd.
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP