Status:
COMPLETED
Reduced Intensity Total Body Irradiation + Thymoglobulin Followed by Allogeneic PBSCT
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Non-Hodgkin's Lymphoma
Leukemia
Eligibility:
All Genders
40-70 years
Phase:
PHASE2
Brief 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...
Detailed 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 treat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 21 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2017
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00709592
Start Date
July 21 2008
End Date
June 28 2017
Last Update
November 9 2018
Active Locations (1)
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1
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States, 23298-0037