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Clinical Trials/NCT01364363
NCT01364363CompletedNot Applicable

Allogeneic Hematopoietic Progenitor Cell Transplantation From Unrelated Donors

Scripps Health2 sites in 1 country64 target enrollmentStarted: March 2005Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
64
Locations
2
Primary Endpoint
Bone Marrow and Peripheral Blood Chimerism
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 69 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.
  • •Caregiver must be available while outpatient

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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