Non-Myeloablative Allogeneic Transplant for Myelodysplastic Syndromes and Myeloproliferative Disorders

This study has been completed.

First Received on September 14, 2005. Last Updated on October 13, 2010 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
Myelodysplastic Syndromes Myeloproliferative Disorders Blood and Marrow Transplant (BMT) Myelodysplastic Syndromes (MDS) Myeloproliferative Disorders (MPD)	Procedure: nonmyeloablative allogeneic hematopoietic cell transplant

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

Resource links provided by NLM:

MedlinePlus related topics: Myelodysplastic Syndromes

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

Efficacy of transplant [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

safety profile of nonmyeloablative transplant, graft versus host disease, graft rejection, non-relapse mortality, use of donor lymphocyte infusion [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	December 2001
Study Completion Date:	July 2010
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:	Ginna Laport, Stanford University School of Medicine
ClinicalTrials.gov Identifier:	NCT00186576 History of Changes
Obsolete Identifiers:	NCT00052546
Other Study ID Numbers:	BMT128, 75826, BMT128
Study First Received:	September 14, 2005
Last Updated:	October 13, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Bone Marrow Diseases

Hematologic Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on February 12, 2012