T-cell prolymphocytic leukemia (T-PLL) is a chemotherapy-resistant malignan
cy with a median survival of 7.5 months. Preliminary results indicated a hi
gh remission induction rate with the human CD52 antibody, CAMPATH-1H. This
study reports results in 39 patients with T-PLL treated with CAMPATH-1H bet
ween March 1993 and May 2000. All but 2 patients had received prior therapy
with a variety of agents, including 30 with pentostatin; none achieved com
plete remission (CR). CAMPATH-1H (30 mg) was administered intravenously 3 t
imes weekly until maximal response. The overall response rate was 76% with
60% CR and 16% partial remission (PR). These responses were durable with a
median disease-free interval of 7 months (range, 4-45 months). Survival was
significantly prolonged in patients achieving CR compared to PR or no resp
onse (NR), including one patient who survived 54 months. Nine patients rema
in alive up to 29 months after completing therapy. Seven patients received
high-dose therapy with autologous stem cell support, 3 of whom remain alive
in CR 5, 7, and 15 months after autograft. Stem cell harvests in these pat
ients were uncontaminated with T-PLL cells as demonstrated by dual-color fl
ow cytometry and polymerase chain reaction Four patients had allogeneic ste
m cell transplants, 3 from siblings and 1 from a matched unrelated donor. T
wo had nonmyeloablative conditioning. Three are alive in CR up to 24 months
after allograft. The conclusion is that CAMPATH-1H is an effective therapy
in T-PLL, producing remissions in more than two thirds of patients. The us
e of stem cell transplantation to consolidate responses merits further stud
y. (C) 2001 by The American Society of Hematology.