The trial that this abstract references is the one I will be participating in a week from today. The Principal Investigator sent me a copy of the full article; here are my notes:
Notes on the NIH Campath Study JCO Article
Overall, 68% hematologic improvement (HI) or complete response (CR)
Among INT-1, 77% HI or CR
Among INT-2, 57% HI or CR
81% with HLA-DR15+ responded vs 40% of HLA-DR15-
Among responders:
11% CR in 3 months
18% CR in 6 months
56% CR in 12 months
Median time to any response: 3 months
78% of RBC anemics in the trial were transfusion independent after one year.
Of 21 who responded, 71% are still responding.
6 relapsed and four of those responded to CsA
Temporary Impact on Blood Counts -
35% (11) Anemia
10% (3) neutropenia
39% (12) Thrombocytopenia
All resolved within three months.
75% (24) had infusion reactions -- rigors, malaise.
40% (13) Patients were hospitalized for infections (but the principle investigator in an email exchange told me these were largely folks who were neutropenic before the trial and, as a result, had already been hospitalized for infection before Campath. The post-trial hospitalization was only "possibly" related to Campth. Only one of the 32 patients had an infection "probably" related to the trial -- a reactivation of a prior case of shingles.
Epstein-Barr Virus was reactivated in 48% of those who were positive for it and CMV was reactivated in 23% of those positive for it, but no one got sick from either and both virus populations returned to normal in a median of a couple of weeks.
Those are the highlights. I'd attach a copy of the article, but I'm not sure I can do that given copyright restrictions. If you want a copy
email me and I'll send it along. I'm sure that doesn't violate copyright.
Take Care!
Greg