Clinical trial NCT00709592: Reduced Intensity Total Body Irradiation + Thymoglobulin Followed by Allogeneic PBSCT
Official title: Reduced Intensity Myeloablative Total Body Irradiation and Thymoglobulin Followed by Allogeneic Peripheral Blood Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Leukemia
Multiple Myeloma
Acute Myeloid Leukemia
Hodgkin Lymphoma
Chronic Lymphocytic Leukemia
Chronic Myelogenous Leukemia
Myelodysplastic Syndrome
Keywords: total body irradiation
Allogeneic Peripheral Blood Stem Cell Transplantation
thymoglobulin
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2008-07-03
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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 \</=70 with an ECOG performance status \< 2
* Patients between 18 and 40 years of age will be eligible only if they have co-morbidities precluding conventional allogeneic transplantation with full intensity myeloablative conditioning
* Adequate cardiac, pulmonary, renal and hepatic function for transplant
* Negative serology for HIV
* Negative serum pregnancy test
* Patients who have received therapeutic radiation to a localized field will be eligible, provided critical structure tolerance doses have not been exceeded
* Patients who have had prior myeloablative autologous transplant will be eligible

Exclusion Criteria:

* Evidence of uncontrolled viral, fungal, bacterial infection
* Evidence of active meningeal or CNS disease
* Prior therapy with rabbit ATG, prior treatment with equine ATG is allowed if more than 3 months ago
* Breast feeding mothers are excluded

Primary outcomes:
measure: The 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.
timeFrame: Up to 9 months following transplant
Secondary outcomes:
measure: Engraftment of Donor Hematopoietic Stem Cells, as Measured by Time in Days to Neutrophil and Platelet Count Recovery Following Allogeneic PBSCT.
timeFrame: Up to 52 weeks post transplant.
measure: Survival
timeFrame: 2-year survival rate (%)
measure: Treatment Related Mortality
timeFrame: Day 100
measure: Event-free Survival
timeFrame: 2 years
measure: Relapse
timeFrame: 2 year relapse rate (%)
measure: Donor Lymphocyte Infusion
timeFrame: 2 year rate of DLI
measure: Acute Graft-Versus-Host Disease (GVHD)
timeFrame: 2 year rate (%)
measure: Chronic Graft-Versus-Host Disease (GVHD)
timeFrame: 2 year GVHD rate
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
Study officials:
affiliation: Massey Cancer Center
name: Amir Toor, MD
role: PRINCIPAL_INVESTIGATOR
References: