Reduced Intensity Total Body Irradiation + Thymoglobulin Followed by Allogeneic PBSCT

This study is ongoing, but not recruiting participants.
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Virginia Commonwealth University Identifier:
First received: July 1, 2008
Last updated: March 18, 2015
Last verified: March 2015

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.

Condition Intervention Phase
Non-Hodgkin's Lymphoma
Multiple Myeloma
Acute Myeloid Leukemia
Hodgkin Lymphoma
Chronic Lymphocytic Leukemia
Chronic Myelogenous Leukemia
Myelodysplastic Syndrome
Biological: thymoglobulin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reduced Intensity Myeloablative Total Body Irradiation and Thymoglobulin Followed by Allogeneic Peripheral Blood Stem Cell Transplantation

Resource links provided by NLM:

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • 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. [ Time Frame: Up to 9 months following transplant ] [ Designated as safety issue: No ]
    A positive test result will indicate immune reconstitution, while a negative test results will indicate lack of immune reconstitution. Participants not done (ND) will be counted with the negative (Neg).

Secondary Outcome Measures:
  • Engraftment of Donor Hematopoietic Stem Cells, as Measured by Neutrophil and Platelet Counts [ Time Frame: 12 day median ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: 2-year survival rate (%) ] [ Designated as safety issue: Yes ]
  • Treatment Related Mortality [ Time Frame: Day 100 ] [ Designated as safety issue: Yes ]
  • Event-free Survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Relapse [ Time Frame: 2 year relapse rate (%) ] [ Designated as safety issue: Yes ]
    Patients with different disease relapses was determined according to current clinical standards based on the disease. For example, AML or MDS relapse is determined by a bone marrow biopsy. Multiple myeloma relapse requires a number of labs and/or biopsy to diagnose such as SPEP, UPEP, immunofixation, serum and urine light chains. In lymphoma disease is followed using CT and/or PET scans.

  • Donor Lymphocyte Infusion [ Time Frame: 2 year rate of DLI ] [ Designated as safety issue: Yes ]
  • Acute Graft-Versus-Host Disease (GVHD) [ Time Frame: 2 year rate (%) ] [ Designated as safety issue: Yes ]
  • Chronic Graft-Versus-Host Disease (GVHD) [ Time Frame: 2 year GVHD rate ] [ Designated as safety issue: Yes ]

Enrollment: 41
Study Start Date: July 2008
Estimated Study Completion Date: July 2016
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ATG 7.5 mg/kg
(Rabbit-ATG;Thymoglobulin,Genzyme) ATG 7.5 mg/kg given over three days (day -9 to -7) followed by 450 cGy TBI and tacrolimus plus MMF GVHD prophylaxis.
Biological: thymoglobulin
1.7 mg/kg/day
Other Name: Antithymocyte Globulin (Rabbit)
Experimental: ATG 2.5 mg/kg/d
(Rabbit-ATG;Thymoglobulin,Genzyme) ATG 5.1 mg/kg in three divided doses (2.5 mg/kg/d) given over three days (day -9 to -7) followed by 450 cGy TBI and tacrolimus plus MMF GVHD prophylaxis.
Biological: thymoglobulin
2.5 mg/kg/day
Other Name: Antithymocyte Globulin (Rabbit)

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.


Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00709592

United States, Virginia
Massey Cancer Center/Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0037
Sponsors and Collaborators
Virginia Commonwealth University
Genzyme, a Sanofi Company
Principal Investigator: Amir Toor, MD Massey Cancer Center, VCU
  More Information

Additional Information:
No publications provided

Responsible Party: Virginia Commonwealth University Identifier: NCT00709592     History of Changes
Other Study ID Numbers: MCC-11561
Study First Received: July 1, 2008
Results First Received: February 1, 2015
Last Updated: March 18, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
total body irradiation
Allogeneic Peripheral Blood Stem Cell Transplantation

Additional relevant MeSH terms:
Hodgkin Disease
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Lymphoma, Non-Hodgkin
Multiple Myeloma
Myelodysplastic Syndromes
Blood Protein Disorders
Bone Marrow Diseases
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Myeloproliferative Disorders
Neoplasms by Histologic Type
Neoplasms, Plasma Cell
Precancerous Conditions
Vascular Diseases processed this record on October 09, 2015