Non Hodgkin Lymphoma Clinical Trial

Reduced Intensity Total Body Irradiation + Thymoglobulin Followed by Allogeneic PBSCT

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.

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Full 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.

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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 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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

42

Study ID:

NCT00709592

Recruitment Status:

Completed

Sponsor:

Virginia Commonwealth University

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There is 1 Location for this study

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Virginia Commonwealth University/Massey Cancer Center
Richmond Virginia, 23298, United States

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Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

42

Study ID:

NCT00709592

Recruitment Status:

Completed

Sponsor:


Virginia Commonwealth University

How clear is this clinincal trial information?

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