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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd.
ClinicalTrials.gov Identifier:
NCT01854567
First received: May 13, 2013
Last updated: July 21, 2016
Last verified: July 2016
  Purpose
The study investigates the time to engraftment of a mesenchymal expanded cord blood unit in patients with hematologic malignancies undergoing transplantation with myeloablative conditioning.

Condition Intervention Phase
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
Biological: Infusion of two unexpanded cord blood units.
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Mesoblast, Ltd.:

Primary Outcome Measures:
  • Time to Neutrophil and Platelet Engraftment [ Time Frame: 100 days ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]
  • Percentage of patients with primary graft failure [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Incidence and severity of acute Graft Versus Host Disease [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: February 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
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 one MPC expanded cord unit and one unexpanded cord unit.
Active Comparator: Control
Infusion of two unexpanded cord blood units.
Biological: Infusion of two unexpanded cord blood units.
Umbilical Cord Blood.

  Eligibility

Ages Eligible for Study:   up to 65 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01854567

Locations
United States, Florida
University of Miami Health System Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Weill Cornell-New York Presbyterian Hospital
New York, New York, United States, 10065
Westchester Medical Center
Valhalla, New York, United States, 10595
United States, Ohio
Case Western
Cleveland, Ohio, United States, 44106
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Texas Transplant Center at Methodist Healthcare System
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Mesoblast, Ltd.
Investigators
Study Director: Donna Skerrett, MD, MS Mesoblast, Ltd.
Principal Investigator: Elizabeth J. Shpall, MD M.D. Anderson Cancer Center
  More Information

Responsible Party: Mesoblast, Ltd.
ClinicalTrials.gov Identifier: NCT01854567     History of Changes
Other Study ID Numbers: CB-AB006  2012-0166 
Study First Received: May 13, 2013
Last Updated: July 21, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Mesoblast, Ltd.:
Cord Blood
Stem Cells
MPC
Mesoblast
Expanded
AML
ALL
NHL
Leukemia
Lymphoma

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myeloid
Lymphoma, Non-Hodgkin
Leukemia, Myeloid, Acute
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma

ClinicalTrials.gov processed this record on September 27, 2016