Reduced Intensity Total Body Irradiation + Thymoglobulin Followed by Allogeneic PBSCT

Completed · Phase 2

Conditions studied: Non-Hodgkin's Lymphoma, Leukemia, Multiple Myeloma, Acute Myeloid Leukemia, Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome

In brief

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.

Key facts

Study ID

NCT00709592

Run by

Virginia Commonwealth University

People needed

42

Starts

2008-07-21

Expected to finish

2017-06-28

Last updated by the study team

2018-11-09

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Virginia Commonwealth University/Massey Cancer Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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