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Completed

NCT Number: NCT00709592

Reduced Intensity Total Body Irradiation + Thymoglobulin Followed by Allogeneic PBSCT

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.

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Key information

Conditions

Non-Hodgkin's Lymphoma Acute Myeloid Leukemia Blood Protein Disorders Bone Marrow Diseases Cardiovascular Diseases Chronic Disease Chronic Lymphocytic Leukemia Chronic Myelogenous Leukemia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hodgkin Disease Hodgkin Lymphoma Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma Myelodysplastic Syndrome Myelodysplastic Syndromes Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thymoglobulin

Biological

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.

Other names: anti-thymocyte globulin (rabbit), ATG, Genzyme, anti-thymocyte globulin, Rabbit, Rabbit-ATG

total-body irradiation

Radiation

Undergo TBI

Other names: Whole-Body Irradiation, Total Body Irradiation [TBI]

Allogeneic PBSCT or BMT

Procedure

Undergo allogeneic PBSCT or BMT

Other names: PBPC transplantation, Peripheral Blood Progenitor Cell Transplantation, Peripheral Blood Stem Cell Transplantation [Allogenic PBSCT], Allogeneic Bone Marrow Transplantation [BMT], Allogeneic BMT, Allogeneic Hematopoietic Stem Cell Transplantation, HSCT

Tacrolimus

Drug

Given PO

Other names: Fujimycin, Hecoria, Prograf, Protopic

Mycophenolate mofetil

Drug

Given PO

Other names: CellCept, MMF

Primary outcomes

  1. 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

    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 outcomes

  1. Engraftment of Donor Hematopoietic Stem Cells, as Measured by Time in Days to Neutrophil and Platelet Count Recovery Following Allogeneic PBSCT.

    Time frame: Up to 52 weeks post transplant.

  2. Survival

    Time frame: 2-year survival rate (%)

  3. Treatment Related Mortality

    Time frame: Day 100

  4. Event-free Survival

    Time frame: 2 years

  5. Relapse

    Time frame: 2 year relapse rate (%)

    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.

  6. Donor Lymphocyte Infusion

    Time frame: 2 year rate of DLI

  7. Acute Graft-Versus-Host Disease (GVHD)

    Time frame: 2 year rate (%)

  8. Chronic Graft-Versus-Host Disease (GVHD)

    Time frame: 2 year GVHD rate

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Genzyme, a Sanofi Company

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2014
Study completion
2017
First posted
Jul 3, 2008
Registry last updated
Nov 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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