Reduced Intensity Total Body Irradiation + Thymoglobulin Followed by Allogeneic PBSCT

• Status: Completed
• Trial end date: 2017-06-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborator: Genzyme, a Sanofi Company
• Treatments: Antilymphocyte Serum; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus; Thymoglobulin

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