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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE May 13, 2013
First Posted Date  ICMJE May 15, 2013
Last Update Posted Date September 18, 2018
Actual Study Start Date  ICMJE August 2013
Actual Primary Completion Date September 23, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2013)
Time to Neutrophil and Platelet Engraftment [ Time Frame: 100 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01854567 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 14, 2013)
Incidence and severity of acute Graft Versus Host Disease [ Time Frame: 100 days ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE P3 Study of Umbilical Cord Blood Cells Expanded With MPCs for Transplantation in Patients With Hematologic Malignancies
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Myelogenous Leukemia
  • Acute Lymphoblastic Leukemia
  • Non-Hodgkin's Lymphoma
  • Hodgkin's Disease
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2018)
49
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2013)
240
Actual Study Completion Date  ICMJE May 5, 2017
Actual Primary Completion Date September 23, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01854567
Other Study ID Numbers  ICMJE CB-AB006
2012-0166 ( Other Identifier: UT MDACC )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mesoblast, Ltd.
Study Sponsor  ICMJE Mesoblast, Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Donna Skerrett, MD, MS Mesoblast, Ltd.
Principal Investigator: Elizabeth J. Shpall, MD M.D. Anderson Cancer Center
PRS Account Mesoblast, Ltd.
Verification Date September 2018

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