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

Phase 3

Completed

• Conditions: Acute Myelogenous Leukemia; Acute Lymphoblastic Leukemia; Non-Hodgkin's Lymphoma; Hodgkin's Disease
• Interventions: Biological: Infusion of one MPC expanded cord unit and one unexpanded cord unit; Biological: Infusion of two unexpanded cord blood units.

• Registration Number: NCT01854567
• Lead Sponsor: Mesoblast, Ltd.

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 available

Study Timeline

• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-05-14
• Study First Posted: 2013-05-15
• Study Start: 2013-08
• Primary Completion: 2016-09-23
• Study Completion: 2017-05-05
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-25
• Last Update Posted: 2020-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	Infusion of one MPC expanded cord unit and one unexpanded cord unit	Infusion of one MPC expanded cord unit and one unexpanded cord unit.
Control	Infusion of two unexpanded cord blood units.	Infusion of two unexpanded cord blood units.

Primary Outcome Measures

Name	Time	Method
Time to Neutrophil and Platelet Engraftment	100 days

Secondary Outcome Measures

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

Trial Locations

Locations (9)

Texas Transplant Center at Methodist Healthcare System; 🇺🇸 San Antonio, Texas, United States

Weill Cornell-New York Presbyterian Hospital; 🇺🇸 New York, New York, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Westchester Medical Center; 🇺🇸 Valhalla, New York, United States

Case Western; 🇺🇸 Cleveland, Ohio, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Miami Health System Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States