Umbilical Cord Blood Stem Cell Transplantation in Adults With Advanced Blood Disorders or Cancer - Full Text View

Sponsored by:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00312429

Purpose

Umbilical cord blood is an important source of stem cells and can be used to treat blood and immune system disorders and certain types of cancer. Stem cell transplants of umbilical cord blood have been shown to be effective in treating illness in children, but more research is needed to confirm the benefit of this procedure in adults. The purpose of this study is to examine the immune system response to cord blood stem cell transplantation in adults with advanced blood disorders or cancer.

Condition	Intervention	Phase
Hematologic Neoplasms	Procedure: Stem Cell Transplantation	Phase I Phase II

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Cord Blood Transplantation in Adult Recipients

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Secondary Outcome Measures:

Survival Rates (measured at Year 1)

Estimated Enrollment:	35
Study Start Date:	January 2002
Study Completion Date:	June 2007

Detailed Description:

The use of umbilical cord blood stem cells to treat blood disorders and cancer is an important medical advance; currently, more than 45 disorders can be treated with this method. While bone marrow transplants are the most common method for stem cell donations, research has shown that there are many advantages to using allogeneic grafts of stem cells obtained from umbilical cord blood. Cord blood stem cells are relatively easy to obtain.

Additionally, a perfect donor match is not necessary, thereby decreasing the likelihood of graft-versus-host disease (GVHD), a serious side effect in which donor stem cells attack the recipient's tissues. Cord blood has been used successfully in pediatric patients but its benefit in adults remains untested. The purpose of this study is to evaluate the effectiveness of umbilical cord blood stem cell transplantation in adults with advanced blood disorders or cancer. Upon receiving an allogeneic stem cell transplant using umbilical cord blood, participants will be observed for successful engraftment in which the transplanted stem cells "take" and begin producing new blood cells. The incidence of GVHD and the overall immune system's response will also be examined. In turn, these findings may guide future umbilical cord blood stem cell clinical trials.

This 1-year study will enroll individuals with advanced blood diseases or cancer. Participants will receive an allogeneic umbilical cord blood stem cell transplant and will be closely monitored while in the hospital to determine when engraftment occurs and if GVHD develops. Study visits will occur at Months 1, 2, 3, 6, 9, and Year 1. At each visit, participants will have blood drawn for laboratory testing and for evaluation of immune system response.

Quality of life questionnaires will also be completed at each visit.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis reviewed at transplant center and confirmed to fit the criterion for high risk blood disease or cancer, as defined for the study
Estimated life expectancy of at least 6 weeks following study entry
Cancer and Leukemia Group B (CALGB) performance status less than or equal to 2
White blood cell count, platelet, hematocrit, tuberculosis, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, creatinine, and HIV test results reviewed by transplant center
Multiple gated acquisition (MUGA), echocardiogram, cardiac MRI, and/or pulmonary function tests (PFT) performed and reviewed by transplant center (for individuals with an ejection fraction and diffusing capacity [DLCO] of 40-50%, the appropriate cardiology or pulmonary consultations should be considered if the individual has severe heart or lung disease at the initiation of therapy)
Sufficient number of umbilical cord blood units available for transplantation
If female, willing to use contraception throughout the study

Exclusion Criteria:

Undergoing Interleukin-2 (IL-2) therapy within 8 weeks of study entry
Diagnosed with a medical or psychiatric illness that may interfere with study participation
Pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312429

Locations

United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Nelson J. Chao, MD

Duke University

More Information

No publications provided

Responsible Party:	Duke University ( Nelson Chao )
Study ID Numbers:	364, R01 HL062095-06
Study First Received:	April 6, 2006
Last Updated:	December 12, 2007
ClinicalTrials.gov Identifier:	NCT00312429 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):

Hematological Malignancies
Leukemia
Lymphoma
Myelodysplasia
Multiple Myeloma

Study placed in the following topic categories:

Leukemia
Preleukemia
Hematologic Neoplasms
Hematologic Diseases

Myelodysplastic Syndromes
Lymphoma
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Hematologic Neoplasms
Hematologic Diseases

ClinicalTrials.gov processed this record on May 07, 2009