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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


Phase 3
N/A
65 Years
Open (Enrolling)
Both
Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma, Hodgkin's Disease

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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 CenterHouston, Texas  77030-4096
Case WesternCleveland, Ohio  44106
Texas Transplant Center at Methodist Healthcare SystemSan Antonio, Texas  78229