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Campath Active in Refractory B-CLL With p53 Mutation

Campath Active in Refractory B-CLL With p53 Mutation

ORLANDO—Alemtuzumab (Campath-1H) can induce responses in patients with
refractory B-cell chronic lymphocytic leukemia (B-CLL) who have the 17p-/p53
genetic mutation, which is usually characterized by a dismal outcome, Stephan
Stilgenbauer, MD, of the Department of Internal Medicine III, University of Ulm,
Germany, reported at the 43rd Annual Meeting of the American Society of
Hematology (abstract 3211). The researchers used alemtuzumab to treat 11
patients with B-CLL, as well as 4 with T-prolymphocytic leukemia (T-PLL) and 1
with Sézary syndrome.

The small, single-institution study was based on a larger study that
produced an overall response rate of 33% among 93 B-CLL patients who were
refractory to fludarabine (Fludara) and received alemtuzumab. The previous
study also raised questions about possible associations between the drug and
genetic factors such as 17p-.

The new study involved 16 patients. All 11 B-CLL patients were fludarabine
refractory. The four T-PLL patients and one with Sézary syndrome were also
chemotherapy refractory.

After initial alemtuzumab dose escalation from 3 to 10 to 30 mg, all
patients received three doses at 30 mg IV per week for a maximum of 12 weeks.
Premedication was with antihistamines and acetaminophen, with additional drugs
used for infusion-related side effects and infection control.

One patient with B-CLL received alemtuzumab as in vivo purging as part of
the high-dose regimen given before autologous stem cell transplantation; this
was due to a poor graft with high B-cell contamination.

Responses and Reactions

The B-CLL and T-PLL groups each had one complete responder. In addition,
there were four partial responders in the B-CLL group and two in the T-PLL
group, Dr. Stilgenbauer reported. Responses were rapid in blood and bone marrow
but delayed for splenomegaly and lymphadenopathy.


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