Non-Myeloablative Allogeneic Transplant for Myelodysplastic Syndromes and Myeloproliferative Disorders

This study is ongoing, but not recruiting participants.

First Received: September 14, 2005 Last Updated: May 12, 2009 History of Changes

Sponsor:	Stanford University
Collaborator:	National Institutes of Health (NIH)
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00186576

Purpose

To improve survival outcomes for patients with MDS and MPD with a nonmyeloablative allogeneic hematopoietic cell transplant.

Condition	Intervention
Myeloproliferative Disorders Myelodysplastic Syndromes	Procedure: nonmyeloablative allogeneic hematopoietic cell transplant

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation for Treatment of Myelodysplastic Syndromes and Myeloproliferative Disorders (Except CML)

Further study details as provided by Stanford University:

Primary Outcome Measures:

Efficacy [Time frame 1 year]

Secondary Outcome Measures:

safety profile of nonmyeloablative transplant, GVHD, graft rejection, non-relapse mortality, use of DLI [Time frame 1 year]

Estimated Enrollment:	40
Study Start Date:	December 2001
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	March 2004 (Final data collection date for primary outcome measure)

Detailed Description:

Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation for Treatment of Myelodysplastic Syndromes and Myeloproliferative Disorders (Except CML)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:- Myelodysplastic Syndromes

Myeloproliferative Disorders
HLA matched donor available

Exclusion Criteria:- organ dysfunction

HIV positive

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00186576

Locations

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Ginna Laport

Stanford University

More Information

Publications:

Laport GG, Sandmaier BM, Storer BE, Scott BL, Stuart MJ, Lange T, Maris MB, Agura ED, Chauncey TR, Wong RM, Forman SJ, Petersen FB, Wade JC, Epner E, Bruno B, Bethge WA, Curtin PT, Maloney DG, Blume KG, Storb RF. Reduced-intensity conditioning followed by allogeneic hematopoietic cell transplantation for adult patients with myelodysplastic syndrome and myeloproliferative disorders. Biol Blood Marrow Transplant. 2008 Feb;14(2):246-55.

Responsible Party:	Stanford University School of Medicine ( Ginna Laport, Principal Investigator )
Study ID Numbers:	BMT128, 75826, BMT128, NCT00186576
Study First Received:	September 14, 2005
Last Updated:	May 12, 2009
ClinicalTrials.gov Identifier:	NCT00186576 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Neoplasms
Preleukemia
Pathologic Processes
Disease
Precancerous Conditions

Hematologic Diseases
Syndrome
Myelodysplastic Syndromes
Myeloproliferative Disorders
Bone Marrow Diseases

ClinicalTrials.gov processed this record on November 25, 2009