NCT00709592

Reduced Intensity Total Body Irradiation + Thymoglobulin Followed by Allogeneic PBSCT

Reduced Intensity Myeloablative Total Body Irradiation and Thymoglobulin Followed by Allogeneic Peripheral Blood Stem Cell Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

One of two different doses of thymoglobulin will allow bone marrow engraftment with minimal Graft-versus-Host Disease and allow adequate immune response to allow the transplanted stem cells to replace the tumor cells.

Detailed description

This randomized phase II trial studies how well giving low dose total-body irradiation (TBI) with anti-thymocyte globulin followed by donor peripheral blood stem cell transplant (PBSCT) works in treating patients with hematologic malignancies. Giving reduced intensity total-body irradiation and anti-thymocyte globulin before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving total-body irradiation together with antithymocyte globulin before transplant may stop this from happening.

Conditions

• Non-Hodgkin's Lymphoma
• Leukemia
• Multiple Myeloma
• Acute Myeloid Leukemia
• Hodgkin Lymphoma
• Chronic Lymphocytic Leukemia
• Chronic Myelogenous Leukemia
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Thymoglobulin	Patients eligible for participation in this study will be randomized between receiving rabbit ATG for 3 days. Thymoglobulin will be administered according to VCU BMT standard of care starting day -9 and continued daily through day -7.
RADIATION	Total-Body Irradiation	Undergo TBI
PROCEDURE	Allogeneic PBSCT or BMT	Undergo allogeneic PBSCT or BMT
DRUG	Tacrolimus	Given PO
DRUG	Mycophenolate Mofetil	Given PO

Timeline

• Start date: 2008-07-21
• Primary completion: 2014-02-15
• Completion: 2017-06-28
• First posted: 2008-07-03
• Last updated: 2018-11-09
• Results posted: 2015-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study