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

June 25, 2020 updated by: Mesoblast, Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Health System Sylvester Comprehensive Cancer Center
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10065
        • Weill Cornell-New York Presbyterian Hospital
      • Valhalla, New York, United States, 10595
        • Westchester Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western
    • Texas
      • Houston, Texas, United States, 77030
        • Md Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • Texas Transplant Center at Methodist Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to Neutrophil and Platelet Engraftment
Time Frame: 100 days
100 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects with neutrophil recovery at day 26, platelet recovery at day 60 and subjects alive at day 100
Time Frame: 100 days
100 days
Percentage of patients with primary graft failure
Time Frame: 100 days
100 days

Other Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of acute Graft Versus Host Disease
Time Frame: 100 days
100 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mesoblast, Ltd.

Investigators

  • Principal Investigator: Elizabeth J. Shpall, MD, M.D. Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2013

Primary Completion (ACTUAL)

September 23, 2016

Study Completion (ACTUAL)

May 5, 2017

Study Registration Dates

First Submitted

May 13, 2013

First Submitted That Met QC Criteria

May 14, 2013

First Posted (ESTIMATE)

May 15, 2013

Study Record Updates

Last Update Posted (ACTUAL)

June 26, 2020

Last Update Submitted That Met QC Criteria

June 25, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CB-AB006
  • 2012-0166 (OTHER: UT MDACC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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