This trial is active, not recruiting.

Conditions non-hodgkin's lymphoma, leukemia, multiple myeloma, acute myeloid leukemia, hodgkin lymphoma, chronic lymphocytic leukemia, chronic myelogenous leukemia, myelodysplastic syndrome
Treatments thymoglobulin
Phase phase 2
Sponsor Virginia Commonwealth University
Collaborator Genzyme, a Sanofi Company
Start date July 2008
End date December 2015
Trial size 90 participants
Trial identifier NCT00709592, MCC-11561


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
1.7 mg/kg/d thymoglobulin IV d-9 to -7
thymoglobulin Antithymocyte Globulin (Rabbit)
1.7 mg/kg/day
2.5 mg/kg/d thymoglobulin IV d-9 to d-7
thymoglobulin Antithymocyte Globulin (Rabbit)
2.5 mg/kg/day

Primary Outcomes

The primary endpoint of the study is a comparison of functional immune reconstitution at 6-9 months following transplant as measured by antibody response to vaccination with inactivated Hepatitis A or B vaccine.
time frame: Up to 9 months following transplant

Secondary Outcomes

Engraftment of donor hematopoietic stem cells, as measured by neutrophil and platelet counts
time frame: Up to 52 weeks post-transplant

Eligibility Criteria

Male or female participants from 40 years up to 70 years old.

Inclusion Criteria: - Patients with hematological malignancies for which allogeneic stem cell transplantation indicated including non-Hodgkin lymphoma (NHL), multiple myeloma (MM), acute myeloid leukemia (AML), Hodgkin lymphoma (HD), chronic lymphocytic leukemia (CLL), chronic myelogenous leukemia (CML), and myelodysplastic syndrome (MDS) - Patients with HLA compatible related or unrelated stem cell donor, willing and able to serve as an allogenic HSC donor. Unrelated donors have to be matched at HLA-A, B, C and DRB1 loci. A single locus mismatch will be tolerated in the event a more closely matched donor is not available. - Patients age >/=40 to

Additional Information

Official title Reduced Intensity Myeloablative Total Body Irradiation and Thymoglobulin Followed by Allogeneic Peripheral Blood Stem Cell Transplantation
Principal investigator Amir Toor, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Virginia Commonwealth University.