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

Mesoblast

Status and phase: Completed; Phase 3

Conditions: Acute Myelogenous Leukemia; Non-Hodgkin's Lymphoma; Hodgkin's Disease; Acute Lymphoblastic Leukemia

Treatments: Biological: Infusion of one MPC expanded cord unit and one unexpanded cord unit; Biological: Infusion of two unexpanded cord blood units.

Study type: Interventional

Funder types: Industry

Identifiers

NCT01854567

2012-0166 (Other Identifier)

CB-AB006

Details and patient eligibility

About

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

Enrollment: 49 patients

Sex: All

Ages: Under 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Active

Experimental group

Description:

Infusion of one MPC expanded cord unit and one unexpanded cord unit.

Treatment:

Biological: Infusion of one MPC expanded cord unit and one unexpanded cord unit

Control

Active Comparator group

Description:

Infusion of two unexpanded cord blood units.

Treatment:

Biological: Infusion of two unexpanded cord blood units.