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

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ClinicalTrials.gov Identifier: NCT01854567
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd.

Study Description
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Brief Summary:
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 or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : August 2013
Actual Primary Completion Date : September 23, 2016
Actual Study Completion Date : May 5, 2017

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Time to Neutrophil and Platelet Engraftment [ Time Frame: 100 days ]

Secondary Outcome Measures :
  1. Proportion of subjects with neutrophil recovery at day 26, platelet recovery at day 60 and subjects alive at day 100 [ Time Frame: 100 days ]
  2. Percentage of patients with primary graft failure [ Time Frame: 100 days ]

Other Outcome Measures:
  1. Incidence and severity of acute Graft Versus Host Disease [ Time Frame: 100 days ]

Eligibility Criteria
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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: Mesoblast, Ltd.
ClinicalTrials.gov Identifier: NCT01854567     History of Changes
Other Study ID Numbers: CB-AB006
2012-0166 ( Other Identifier: UT MDACC )
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

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