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Reduced Intensity Total Body Irradiation + Thymoglobulin Followed by Allogeneic PBSCT

CompletedPhase 2

Sponsor: Virginia Commonwealth University

Conditions: Non-Hodgkin's Lymphoma, Leukemia, Multiple Myeloma, Acute Myeloid Leukemia, Hodgkin Lymphoma

Interventions: Thymoglobulin, Total-Body Irradiation, Allogeneic PBSCT or BMT, Tacrolimus, Mycophenolate Mofetil

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 40 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Richmond, Virginia, United States