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Completed

NCT Number: NCT01854567

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

The study investigates the time to engraftment of a mesenchymal expanded cord blood unit in patients with hematologic malignancies undergoing transplantation with myeloablative conditioning.

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Key information

Conditions

Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Hodgkin Disease Hodgkin's Disease Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Non-Hodgkin's Lymphoma Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

Up to 65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 two unexpanded cord blood units.

Biological

Umbilical Cord Blood.

Primary outcomes

  1. Time to Neutrophil and Platelet Engraftment

    Time frame: 100 days

Secondary outcomes

  1. Proportion of subjects with neutrophil recovery at day 26, platelet recovery at day 60 and subjects alive at day 100

    Time frame: 100 days

  2. Percentage of patients with primary graft failure

    Time frame: 100 days

Other outcomes

  1. Incidence and severity of acute Graft Versus Host Disease

    Time frame: 100 days

Sponsors and collaborators

Lead sponsor

Mesoblast, Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
May 15, 2013
Registry last updated
Jun 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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