CLINICAL NEWS
Does the Addition of ATLG Improve Outcomes After Allogeneic Transplantation ?
Previous studies have suggested that adding anti-T lymphocyte globulin ( ATLG ) to the treatment regimen for patients undergoing allogeneic hematopoietic cell transplantation ( alloHCT ) could reduce the incidence of acute and chronic graft-versus-host disease ( aGVHD ; cGVHD ), but a randomized , double-blind , phase III trial presented at the 2016 ASH Annual Meeting showed mixed results .
After two years of follow-up , the addition of ATLG to a standard prophylactic regimen of tacrolimus and methotrexate was found to lower the risk of grade 2-4
aGVHD and moderate-to-severe cGVHD in patients with acute myeloid leukemia ( AML ) or acute lymphocytic leukemia ( ALL ). However , ATLG-treated patients also had lower rates of overall survival ( OS ) and progression-free survival ( PFS ), compared with patients who received placebo .
Robert J . Soiffer , MD , from the Department of Medical Oncology at the Dana Farber Cancer Institute in Boston , Massachusetts , and authors analyzed the incidence of GVHD in 254 patients ( median age = 48 years ; range = 18-65 years ) who had AML ( 64 %), ALL ( 21 %), or myelodysplastic syn-
ABR by dosing regimen
Dosing was investigator determined to meet individual patients ’ needs 1
Patients who generally began the study with fewer bleeds and a lower percentage of target joints were selected for
2x / week prophylaxis
and experienced 1 , 2
Patients who generally began the study with more bleeds and a higher percentage of target joints were selected for
3x / week prophylaxis
and experienced 1 , 2
1
(
Median ABR
n = 18 ) ( IQR = 0.0 ; 8.0 )
Median dose :
35.0 IU / kg ( range : 21-42 IU / kg )
IQR = interquartile range .
2
Median ABR
( n = 44 ) ( IQR = 0.5 ; 5.0 )
Print-only content
Median dose :
31.1 IU / kg ( range : 24-43 IU / kg )
87 % of bleeding episodes resolved with ≤2 infusions of KOVALTRY ® 1
inhibitors
in the completed study of
62 previously treated patients 1
People with hemophilia A may develop inhibitors to rFVIII . People with a history of inhibitors were excluded from LEOPOLD I . 1
SELECTED IMPORTANT SAFETY INFORMATION
Neutralizing antibody ( inhibitor ) formation can occur following administration of KOVALTRY ® . Previously untreated patients ( PUPs ) are at greatest risk for inhibitor development with all Factor VIII products . Carefully monitor patients for the development of Factor VIII inhibitors , using appropriate clinical observations and laboratory tests . If expected plasma Factor VIII activity levels are not attained or if bleeding is not controlled as expected with administered dose , suspect the presence of an inhibitor .