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


Phase 2
40 Years
70 Years
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma, Leukemia, Multiple Myeloma, Acute Myeloid Leukemia, Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome

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Trial Information

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


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.


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
- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Description:

A positive test result will indicate immune reconstitution, while a negative test results will indicate lack of immune reconstitution.

Outcome Time Frame:

Up to 9 months following transplant

Safety Issue:

No

Principal Investigator

Amir Toor, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massey Cancer Center, VCU

Authority:

United States: Institutional Review Board

Study ID:

MCC-11561

NCT ID:

NCT00709592

Start Date:

July 2008

Completion Date:

July 2016

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Leukemia
  • Multiple Myeloma
  • Acute Myeloid Leukemia
  • Hodgkin Lymphoma
  • Chronic Lymphocytic Leukemia
  • Chronic Myelogenous Leukemia
  • Myelodysplastic Syndrome
  • total body irradiation
  • Allogeneic Peripheral Blood Stem Cell Transplantation
  • thymoglobulin
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location
Massey Cancer Center/Virginia Commonwealth University Richmond, Virginia  23298