Clinical trial NCT01854567: P3 Study of Umbilical Cord Blood Cells Expanded With MPCs for Transplantation in Patients With Hematologic Malignancies
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Myelogenous Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin's Lymphoma
Hodgkin's Disease
Keywords: Cord Blood
Stem Cells
MPC
Mesoblast
Expanded
AML
ALL
NHL
Leukemia
Lymphoma
Lead sponsor: Mesoblast, Ltd.
Sponsor class: INDUSTRY
First posted: 2013-05-15
Enrollment: 49
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Time to Neutrophil and Platelet Engraftment
timeFrame: 100 days
Secondary outcomes:
measure: Proportion of subjects with neutrophil recovery at day 26, platelet recovery at day 60 and subjects alive at day 100
timeFrame: 100 days
measure: Percentage of patients with primary graft failure
timeFrame: 100 days
Other outcomes:
measure: Incidence and severity of acute Graft Versus Host Disease
timeFrame: 100 days
Locations:
city: Miami
country: United States
facility: University of Miami Health System Sylvester Comprehensive Cancer Center
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Weill Cornell-New York Presbyterian Hospital
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Cleveland
country: United States
facility: Case Western
state: Ohio
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Texas Transplant Center at Methodist Healthcare System
state: Texas
Study officials:
affiliation: Mesoblast, Ltd.
name: Donna Skerrett, MD, MS
role: STUDY_DIRECTOR
affiliation: M.D. Anderson Cancer Center
name: Elizabeth J. Shpall, MD
role: PRINCIPAL_INVESTIGATOR
References: