T-Regulatory Cell Kinetics for Patients Receiving Alemtuzumab and Undergoing Stem Cell Transplantation From HLA Mismatched-related or HLA Matched- or Mismatched- Unrelated Donors
- To define the biologic recovery and behavior of T-regulatory cells in patients
undergoing stem cell transplantation.
- To determine if the administration of alemtuzumab as part of conditioning therapy to
patients undergoing stem cell transplantation from mismatched-related donors or from
matched-unrelated donors permits T-regulatory cell recovery.
OUTLINE: This is a multicenter study.
- Stem cell transplantation conditioning regimen: Patients receive cytarabine IV every 12
hours for 6 doses starting on day -8*, cyclophosphamide IV once daily on days -7 and
-6, alemtuzumab IV on days -4 to -1, and undergo total body irradiation (TBI) twice
daily on days -4 to -1 (total of 8 fractions). Patients with CNS disease will receive
additional irradiation to the craniospinal axis.
NOTE: *Patients with T-cell lymphoma do not receive cytarabine.
- Stem cell transplantation: Patients undergo stem cell transplantation on day 0.
- Graft-versus-host-disease (GVHD) prevention: Patients receive tacrolimus IV beginning
on day -2, and continuing according to institutional guidelines, followed by a taper.
Patients also receive methotrexate IV on days +1, +3, +6, and +11.
Blood or bone marrow samples will be collected periodically for regulatory T-cell assay.
After completion of study treatment, patients are followed once a month for 6 months, at 9
months, and at 1, 2, and 3 years.
Masking: Open Label, Primary Purpose: Treatment
Biologic recovery and behavior of T-regulatory cells in patients undergoing stem cell transplantation
Robert Krance, MD
Baylor College of Medicine
|Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital||Houston, Texas 77030-2399|
|Dan L. Duncan Cancer Center at Baylor College of Medicine||Houston, Texas 77030|