Non-Myeloablative Allogeneic Transplant for Myelodysplastic Syndromes and Myeloproliferative Disorders

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00186576
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 40
• Location: 1
• Duration (Months): 103
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndromes; Myeloproliferative Disorders; Blood and Marrow Transplant (BMT); Myelodysplastic Syndromes (MDS); Myeloproliferative Disorders (MPD)	Procedure: nonmyeloablative allogeneic hematopoietic cell transplant	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation for Treatment of Myelodysplastic Syndromes and Myeloproliferative Disorders (Except CML)
• Study Start Date: Dec 1, 2001
• Actual Primary Completion Date: Mar 1, 2004
• Actual Study Completion Date: Jul 1, 2010

Outcome Measures

Primary Outcome Measures

1. Efficacy of transplant [1 year]

Secondary Outcome Measures

1. safety profile of nonmyeloablative transplant, graft versus host disease, graft rejection, non-relapse mortality, use of donor lymphocyte infusion [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:- Myelodysplastic Syndromes

• Myeloproliferative Disorders

• HLA matched donor available Exclusion Criteria:- organ dysfunction

• HIV positive

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00186576
• Other Study ID Numbers: BMT128; 75826; BMT128; NCT00052546
• First Posted: Sep 16, 2005
• Last Update Posted: Oct 14, 2010
• Last Verified: Oct 1, 2010

• Additional relevant MeSH terms: Preleukemia; Myelodysplastic Syndromes; Myeloproliferative Disorders; Disease; Syndrome

Study Results

No Results Posted as of Oct 14, 2010