Allo BMT in Advanced Leukemia or High Grade Lymphoma

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00186290
• Collaborator: (none)
• Enrollment: 145
• Location: 1
• Duration (Months): 238
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

To evaluate the role of ablative allogeneic hematopoietic cell transplantation in the treatment of advanced leukemia or lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Non-Hodgkin; Leukemia; Blood and Marrow Transplant (BMT); Lymphomas: Non-Hodgkin	Procedure: ablative allogeneic hematopoietic cell transplantation	N/A

Detailed Description

To determine the disease free survival and overall survival of patients with ALL and ANLL after induction failure, in relapse, or subsequent remission from CML in several phases or recurrent lymphoblastic lymphoma who receive fractionated TBI, etoposide and cyclophosphamide followed by allogenic bone marrow grafting from histocompatible sibling donors. Fractionated Total Body Irradiation (FTBI), Etoposide (VP-16) and Cyclophosphamide (CY) Followed by Allogeneic Bone Marrow Transplantation for Patients with Advanced Leukemia or High Grade Lymphoma

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 145 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Fractionated Total Body Irradiation (FTBI), Etoposide (VP-16) and Cyclophosphamide (CY) Followed by Allogeneic Bone Marrow Transplantation for Patients With Advanced Leukemia or High Grade Lymphoma
• Study Start Date: Dec 1, 1989
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Outcome Measures

Primary Outcome Measures

1. overall survival [october 2009]

2. disease free survival [October 2009]

Secondary Outcome Measures

1. early and late toxicities of the treatment regimen [October 2009]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:HLA identical donor

• adequate organ function

• other life threatening disease

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: Robert Lowsky, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00186290
• Other Study ID Numbers: BMT34; 74165; BMT34
• First Posted: Sep 16, 2005
• Last Update Posted: Oct 11, 2010
• Last Verified: Oct 1, 2010

• Additional relevant MeSH terms: Lymphoma; Leukemia; Lymphoma, Non-Hodgkin

Study Results

No Results Posted as of Oct 11, 2010