Stem Cell Transplant From Matched Unrelated or Partially Matched Related Donors

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00186225
• Collaborator: (none)
• Enrollment: 250
• Location: 1
• Duration (Months): 245.9
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

To evaluate the use of unrelated donors for hematopoietic cell transplantation in the treatment of hematologic and lymphoid malignancies.

Condition or Disease	Intervention/Treatment	Phase
Blood Cancer; Blood and Marrow Transplant (BMT)	Procedure: ablative allogeneic hematopoietic cell transplantation	N/A

Detailed Description

Stem Cell Transplantation from Matched Unrelated or Partially Matched Related Donors Using a Preparatory Regimen Consisting of Fractionated Total Body Irradiation (FTBI) and Cyclophosphamide (CY). To administer high dose radio-chemotherapy followed by stem cell transplantation from a matched unrelated donor or a partially matched related donor.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 250 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Stem Cell Transplantation From Matched Unrelated or Partially Matched Related Donors Using a Preparatory Regimen Consisting of Fractionated Total Body Irradiation (FTBI) and Cyclophosphamide (CY)
• Study Start Date: Nov 1, 1989
• Actual Primary Completion Date: Jun 1, 2007
• Actual Study Completion Date: May 1, 2010

Outcome Measures

Primary Outcome Measures

1. oxicity and efficacy of TBI and cyclophosphamide as preparation for hematopoietic cell transplantation from partially matched and unrelated donors. []

Secondary Outcome Measures

1. Overall Survival []

2. Event Free Survival []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Weeks to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:- acute leukemia

• chronic leukemia

• lymphoblastic lymphoma

• MDS

• MPS 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

Investigators

• Principal Investigator: Laura Johnston, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT00186225
• Other Study ID Numbers: IRB-13390; 75268; BMT22
• First Posted: Sep 16, 2005
• Last Update Posted: Apr 9, 2020
• Last Verified: Apr 1, 2020

• Additional relevant MeSH terms: Hematologic Neoplasms

Study Results

No Results Posted as of Apr 9, 2020