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Prepublished online as a Blood First Edition Paper on March 27, 2003; DOI 10.1182/blood-2003-01-0014.

Submitted January 3, 2003
Accepted March 20, 2003
Phase II study of rituximab in the treatment of cladribine-failed patients with hairy cell leukemia
Jorge Nieva, Kelly Bethel, and Alan Saven*
Division of Hematology and Oncology, Scripps Clinic, La Jolla, CA, USA
Department of Pathology, Scripps Clinic, La Jolla, CA, USA
* Corresponding author; email: saven.alan{at}scrippshealth.org.
Hairy cell leukemia (HCL) is an indolent B-cell neoplasm, strongly expressing CD20. Despite initial very high response rates following cladribine, many patients (pts.) ultimately relapse. Twenty-four HCL pts.(21 male, 3 female), with a median age of 53.5 years, having relapsed after prior treatment with cladribine, were treated with rituximab at 375mg/m2 intravenously weekly x 4. Three pts. (13%) achieved complete remissions and 3 pts. (13%) partial responses. Thus, six of 24 (25%) pts. achieved a response following rituximab. At a median follow-up of 14.6 months, 2 responders have relapsed; median time to relapse not yet reached. The only grade III or IV toxicities demonstrated were culture-negative febrile neutropenia, transient and reversible disseminated intravascular coagulation related to rituximab administration, and a diverticular abscess, each in single patients. Of 18 non-responders, 9 pts. subsequently received other treatments; 5 pts. were retreated with cladribine, 3 underwent splenectomy and 1 received pentostatin. Follow up data are available on 7 of these 9 patients; all 7 patients achieved improvements in hematologic parameters. Rituximab, administered at this dose and schedule, has only modest single agent activity in cladribine-failed HCL patients when compared to other agents active in this disease.

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