Pilot Study of Reduced-Intensity Umbilical Cord Blood Transplantation in Adult Patients Wtih Advanced Hematopoietic Malignancies
This is a pilot study designed to evaluate the safety and feasibility of performing umbilical cord blood transplants in older adults or younger infirm patients with high-risk hematopoeitic malignancies. A novel reduced-intensity preparative regimen for umbilical cord blood transplantation will be used. One to a maximum of three cord blood units, depending on cell count, will be administered to facilitate engraftment. Ten patients will be enrolled with an expected accrual rate of 3-4 patients per year and with a goal of completing accrual within 2-3 years.
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Chronic Myelogenous Leukemia
Low-grade NHL and Chronic Lymphocytic Leukemia
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Pilot Study of Reduced-Intensity Umbilical Cord Blood Transplantation in Adult Patients Wtih Advanced Hematopoietic Malignancies|
|Study Start Date:||August 2004|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
- To assess the feasibility of performing umbilical cord blood transplants in older adults or younger infirm patients using a reduced-intensity preparative regimen. Feasibility of the procedure is defined as an engraftment rate of >80% at Day 180 post-transplantation and a transplant related mortality (TRM) of <50% at Day 100. A TRM of >50% will be considered unacceptable.
- To describe the time to neutrophil and platelet recovery following mini-UCB transplantation.
- To assess lineage-specific chimerism following transplantation and to describe the contribution of each individual CB unit to post-transplantation hematopoeisis.
- To describe disease-specific, event-free and overall survival rates at 180 and 360 days.
- To describe the incidence, severity, and timing of acute and chronic GVHD following reduced-intensity UCB transplantation.
- To evaluate T-cell, B-cell, and NK cell recovery following reduced-intensity UCB transplantation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513318
|United States, California|
|University of California San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Thomas G. Martin, M.D.||University of California, San Francisco|