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
Phase 3
N/A
65 Years
N/A
65 Years
Open (Enrolling)
Both
Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma, Hodgkin's Disease
Both
Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma, Hodgkin's Disease
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to Neutrophil and Platelet Engraftment
Outcome Time Frame:
100 days
Safety Issue:
No
Principal Investigator
Donna Skerrett, MD, MS
Investigator Role:
Study Director
Investigator Affiliation:
Mesoblast, Ltd.
Authority:
United States: Food and Drug Administration
Study ID:
CB-AB006
NCT ID:
NCT01854567
Start Date:
February 2013
Completion Date:
July 2018
Related Keywords:
- Acute Myelogenous Leukemia
- Acute Lymphoblastic Leukemia
- Non-Hodgkin's Lymphoma
- Hodgkin's Disease
- Cord Blood
- Stem Cells
- MPC
- Mesoblast
- Expanded
- AML
- ALL
- NHL
- Leukemia
- Lymphoma
- Hodgkin Disease
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
- Lymphoma
- Lymphoma, Non-Hodgkin
- Hematologic Neoplasms
Name | Location |
|---|---|
| MD Anderson Cancer Center | Houston, Texas 77030-4096 |
| Case Western | Cleveland, Ohio 44106 |
| Texas Transplant Center at Methodist Healthcare System | San Antonio, Texas 78229 |
