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

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

Official Title
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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

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

Intervention / Treatment
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* Biological: Infusion of one MPC expanded cord unit and one unexpanded cord unit
* Biological: Infusion of two unexpanded cord blood units.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>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<br>* Infusion of one MPC expanded cord unit and one unexpanded cord unit.<br>|
| Active Comparator: Control<br>Infusion of two unexpanded cord blood units. | Biological: Infusion of two unexpanded cord blood units.<br>* Umbilical Cord Blood.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Neutrophil and Platelet Engraftment |  | 100 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cord Blood, Stem Cells, MPC, Mesoblast, Expanded, AML, ALL, NHL, Leukemia, Lymphoma