Pilot Study of Umbilical Cord Blood Transplantation in Adult Patient With Advanced Hematopoietic Malignancies
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|ClinicalTrials.gov Identifier: NCT00514722|
Recruitment Status : Terminated (low accrual)
First Posted : August 10, 2007
Last Update Posted : August 14, 2013
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Myelodysplasia Acute Lymphoblastic Leukemia Chronic Myelogenous Leukemia Multiple Myeloma Lymphoma, Large-Cell, Diffuse Lymphoma, Mantle-Cell Lymphoma, T-Cell, Peripheral T-NK Cell Lymphoma Hodgkin Disease||Other: umbilical cord stem cells||Not Applicable|
This study intends to demonstrate an engraftment rate of >80% at day 100 post-transplantation and a transplant related mortality rate of < or equal to 50%. A TRM of >50% will be considered unacceptable. The present research will also:
- Evaluate the toxicity of busulfan, fludarabine, and etoposide as preparative therapy prior to umbilical cord blood cell transplantation.
- Evaluate neutrophil and platelet recovery following UCB transplantation.
- Evaluate lineage-specific chimerism following transplantation and to assess the contribution of each individual CB unit to post-transplantation hematopoiesis.
- Evaluate event free and overall survival.
- Evaluate the incidence, severity and timing of acute and chronic GVHD following UCB transplantation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Umbilical Cord Blood Transplantation in Adult Patient With Advanced Hematopoietic Malignancies|
|Study Start Date :||October 2002|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
- Other: umbilical cord stem cells
umbilical cord stem cell allogeneic transplantation
- efficacy [ Time Frame: 5 years ]
- safety of umbilical cord transplant [ Time Frame: 5 years ]
- safety of umbilical cord stem cell transplant [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514722
|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|