Safety Study of MultiStem® in Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplasia
The purpose of this study is to determine if MultiStem® can safely be given to patients with acute leukemia, chronic myeloid leukemia, or myelodysplasia after they have received hematopoietic stem cell transplantation.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Phase I, Multicenter, Dose-Escalation Trial Evaluating Maximum-Tolerated Dose of Single and Repeated Administration of Allogeneic MultiStem® in Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplasia|
- maximum tolerated dose [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- incidence of grade III/IV GVHD [ Time Frame: 100 days ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Study Completion Date:||November 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Experimental: Single dose Arm
There will be six cohorts of three patients each. Three escalating doses of MultiStem will be evaluated.
Patients will receive a single IV infusion of MultiStem® 2 days after HSCT.
Experimental: Repeat Dose Arm
There will be six cohorts of three patients each. Four dosing regimens will be evaluated,varying doses at three times weekly or five times weekly.
Patients will receive either 3 weekly IV infusions or 5 weekly infusions of MultiStem®
Graft-vs.-Host Disease (GVHD) is one of the major limitations of allogeneic hematopoietic stem cell transplants (HSCT). This complication is major cause of morbidity and mortality and is thought to be initiated by activation of donor T-cells through recognition of "foreign" cells resident in the transplant recipient. Acute GVHD is associated with damage to the liver, skin, gastrointestinal tract and mucosa. Moderate to severe GVHD Grades II-IV occurs in 30-50% of matched related HSCTs and 50-70% of unrelated donor recipients. Severe GHVD requires intense immunosuppression involving steroids and additional agents to get it under control, and patients may develop severe infections as a result of such immunosuppression. An agent or cell therapy that could reduce the incidence and/or severity of GVHD without increasing relapse or infectious risk in HSCT patients would provide substantial benefits.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00677859
|United States, Arizona|
|Mayo Clinic Hospital|
|Phoenix, Arizona, United States, 85054|
|United States, Ohio|
|University Hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|United States, Oregon|
|Oregon State University Medical Center|
|Portland, Oregon, United States, 97239|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|Texas Transplant Institute|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Richard Maziarz, MD||Oregon Health and Science University|
|Principal Investigator:||Steven Devine, MD||Ohio State University|
|Principal Investigator:||Hillard Lazarus, MD||Case Western Reserve University|