Allogeneic Hematopoietic Progenitor Cell Transplantation From Unrelated Donors

Scripps Health1 site in 1 country64 target enrollmentMarch 2005

ConditionsSevere Aplastic Anemia Paroxysmal Nocturnal Hemoglobinuria Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndromes Myeloproliferative Syndromes Chronic Myelogenous Leukemia Hodgkin's Lymphoma Non-Hodgkin's Lymphoma Multiple Myeloma Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Large Granulocytic Leukemia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Severe Aplastic Anemia
Sponsor: Scripps Health
Enrollment: 64
Locations: 1
Primary Endpoint: Bone Marrow and Peripheral Blood Chimerism
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to provide an opportunity for patients with malignancies or bone marrow failure states who lack a suitable sibling donor to undergo allogeneic hematopoietic progenitor cell transplantation using cells from unrelated individuals or cord blood registries.

Detailed Description

same

Registry

clinicaltrials.gov

Start Date

March 2005

End Date

July 2015

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Scripps Health

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•\> 18 years of Age
•\< 70 years
•ECOG performance status 0, 1 or 2
•Left Ventricular Ejection Fraction \> 30%
•Creatinine clearance \> 40ml/min
•Transaminases \< 2X normal
•Total bilirubin \< 2X normal
•HIV seronegativity
•Weight \< 70kg for cord blood transplantation
•Ability to cover the cost of the transplant, necessary medications, and transportation/housing.

Exclusion Criteria

•Greater than one antigen mismatch at HLA-A, B, C or DR plus one allele mismatch at HLA-A, B, C or DR

Outcomes

Primary Outcomes

Bone Marrow and Peripheral Blood Chimerism

Time Frame: 365 days post-transplant

Percent of donor and host cells in peripheral blood and bone marrow will be measured by short tandem repeat (STR) testing and/or standard cytogenetic testing.