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

Sponsor
Mesoblast, Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01854567
Collaborator
(none)
49
Enrollment
9
Locations
2
Arms
45.1
Actual Duration (Months)
5.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • 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

Study Type:
Interventional
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 :
Aug 1, 2013
Actual Primary Completion Date :
Sep 23, 2016
Actual Study Completion Date :
May 5, 2017

Arms and Interventions

ArmIntervention/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

Primary Outcome Measures

  1. Time to Neutrophil and Platelet Engraftment [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 [100 days]

  2. Percentage of patients with primary graft failure [100 days]

Other Outcome Measures

  1. Incidence and severity of acute Graft Versus Host Disease [100 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

SiteCityStateCountryPostal Code
1University of Miami Health System Sylvester Comprehensive Cancer CenterMiamiFloridaUnited States33136
2Moffitt Cancer CenterTampaFloridaUnited States33612
3Beth Israel Deaconess Medical CenterBostonMassachusettsUnited States02215
4Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States10065
5Weill Cornell-New York Presbyterian HospitalNew YorkNew YorkUnited States10065
6Westchester Medical CenterValhallaNew YorkUnited States10595
7Case WesternClevelandOhioUnited States44106
8MD Anderson Cancer CenterHoustonTexasUnited States77030
9Texas Transplant Center at Methodist Healthcare SystemSan AntonioTexasUnited States78229

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mesoblast, Ltd.
ClinicalTrials.gov Identifier:
NCT01854567
Other Study ID Numbers:
  • CB-AB006
  • 2012-0166
First Posted:
May 15, 2013
Last Update Posted:
Jun 26, 2020
Last Verified:
Jun 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mesoblast, Ltd.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 26, 2020