P3 Study of Umbilical Cord Blood Cells Expanded With MPCs... | NCT01854567

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

NCT01854567

Sponsor

Mesoblast, Ltd.

Status

Completed

Last Update Posted

Jun 26, 2020Actual

Enrollment

49Actual

Phase

Phase 3

Conditions

Acute Myelogenous Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin's Lymphoma
Hodgkin's Disease

Interventions

Infusion of one MPC expanded cord unit and one unexpanded cord unit
Infusion of two unexpanded cord blood units.

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2012-0166	Other Identifier	UT MDACC

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013Actual

Primary Completion Date

Sep 23, 2016Actual

Completion Date

May 5, 2017Actual

First Submitted Date

May 13, 2013

First Submission Date that Met QC Criteria

May 14, 2013

First Posted Date

May 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2020

Last Update Posted Date

Jun 26, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active	Experimental	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
Control	Active Comparator	Infusion of two unexpanded cord blood units.	Biological: Infusion of two unexpanded cord blood units.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.	Active

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Neutrophil and Platelet Engraftment		100 days

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Donna Skerrett, MD, MS	Mesoblast, Ltd.	Study Director
Elizabeth J. Shpall, MD	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Miami Health System Sylvester Comprehensive Cancer Center		Miami	Florida	33136	United States

ID	Term
D015470	Leukemia, Myeloid, Acute
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D008228	Lymphoma, Non-Hodgkin
D006689	Hodgkin Disease
D007938	Leukemia
D008223	Lymphoma

ID	Term
D007951	Leukemia, Myeloid
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D007945	Leukemia, Lymphoid
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases