NCT00511537

Brief Summary

This study performs HLA matched stem cell transplantation from unrelated donors in adults who require stem cell transplantation but do not have a matched related donor available. The incidence of graft-versus-host disease in unrelated stem cell transplantation is recorded. This study also monitors the activity and toxicity of total body irradiation and cyclosphosphamide followed by stem cell transplantation from matched unrelated donors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

August 2, 2013

Status Verified

August 1, 2013

Enrollment Period

10.4 years

First QC Date

August 2, 2007

Last Update Submit

August 1, 2013

Conditions

CMLALLAMLMyelodysplasiaLymphomaMyeloproliferative Disorders

Keywords

AMLALLCMLLymphomaMyelodysplasiaUnrelated stem cell transplantationHematopoietic disorders

Eligibility Criteria

Age16 Years - 54 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with Hematopoeietic Disorders

You may qualify if:

  • Age \>15 and \<55
  • Adequate renal function with serum creatinine \<2.0 mg/dl
  • Pulmonary diffusing capacity\>50% of predicted
  • Cardiac ejection fraction \>40% as measured by radionuclide wall motion study or echocardiography
  • Total bilirubin must be \<2.5 mg/dl.
  • Alkaline phosphatase and AST must be less than three times the upper limit of normal
  • Negative serology for the human immunodeficiency virus
  • Available HLA-matched donor
  • Signed informed consent

You may not qualify if:

  • No fully or single-antigen-mismatched sibling donor is available to donate stem cells
  • No active liver disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Anemia, Refractory, with Excess of BlastsLymphomaMyeloproliferative Disorders

Condition Hierarchy (Ancestors)

Anemia, RefractoryAnemiaHematologic DiseasesHemic and Lymphatic DiseasesMyelodysplastic SyndromesBone Marrow DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Thomas G. Martin, M.D.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2007

First Posted

August 6, 2007

Study Start

January 1, 1999

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

August 2, 2013

Record last verified: 2013-08

Locations

US(1)