Non-Myeloablative Allogeneic Transplant for Myelodysplastic Syndromes and Myeloproliferative Disorders - Tabular View

Tracking Information

First Received Date ^ICMJE

September 14, 2005

Last Updated Date

May 12, 2009

Start Date ^ICMJE

December 2001

Estimated Primary Completion Date

March 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Efficacy [Time frame 1 year]

Original Primary Outcome Measures ^ICMJE

Efficacy

Change History

Complete list of historical versions of study NCT00186576 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

safety profile of nonmyeloablative transplant, GVHD, graft rejection, non-relapse mortality, use of DLI

Descriptive Information

Brief Title ^ICMJE

Non-Myeloablative Allogeneic Transplant for Myelodysplastic Syndromes and Myeloproliferative Disorders

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Condition ^ICMJE

Myeloproliferative Disorders
Myelodysplastic Syndromes

Intervention ^ICMJE

Procedure: nonmyeloablative allogeneic hematopoietic cell transplant

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2010

Estimated Primary Completion Date

March 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:- Myelodysplastic Syndromes

Myeloproliferative Disorders
HLA matched donor available

Exclusion Criteria:- organ dysfunction

HIV positive

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00186576

Responsible Party

Ginna Laport, Principal Investigator, Stanford University School of Medicine

Study ID Numbers ^ICMJE

BMT128, 75826, BMT128, NCT00186576

Study Sponsor ^ICMJE

Stanford University

Collaborators ^ICMJE

National Institutes of Health (NIH)

Investigators ^ICMJE

Principal Investigator:

Ginna Laport

Stanford University

Information Provided By

Stanford University

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP