Abstract 4415

The aim of this study was to explore the efficiency of treatment with Alemtuzumab (A.) of chronic lymphocytic leukemia (CLL) patients (pts) refractory to Fludarabine(F.).

Meterials and methods

We observed 6 pts (3 male and 3 female). The median age was 56 years old(52-69). 4 of the pts had Rai stage I desease, 1 patient had Rai stage III, 1 had Rai stage IV. We revealed that 4 pts had 17p deletion with high level, 1 patient did not have del 17p, 1 - was not assessed. High level of the expression of CD38+ was determined, the median number was 37,3%(15-82). All pts were pretreated with Chlorambucil, COP, CHOP, FC for 18 months(7-48). All pts were refractory to F. 5 pts received A. monotherapy during median 9 weeks (2-18). Subcutaneous(SQ) A. dose escalation: 3mg-10mg-30mg on days 1,3,5, followed by 30mg Monday, Wednesday and Friday for 17 weeks. 1 patient received 5 courses FluCam(A. 30 mg 1,2,3 days IV after dose escalation 3mg-10mg-30mg, F. 25mg/m2 1,2,3 days). All pts received PCP, herpes and cytomegalovirus(CMV) and fungal prophylaxis as well as CMV viral DNA monitoring.

Responses were based on NCI-WG 1996 criteria. Minimal residual disease (MRD) was measured in peripheral blood and bone marrow aspirate using flow cytometry for CD19+/CD5+/CD23+ lymphocytes.

Results

The efficiency of the treatment of CLL pts was following: 2 pts (33,3%) displayed disease progression(PD) in 2 and 4 weeks of A. monotherapy, 2 pts achived (33,3%) CR in 14 and 16 weeks, 2 pts (33,3%), achived PR, among them 1 patient showed PR after 5 FluCam courses, the other — after 14 weeks of A. monotherapy. At the completion of the study 4 pts (66,6%) had no evidence of MRD by flow cytometry(<0,01%).

Conclusion

Obtained results showed high effectiveness of A. and acceptable toxity, among resistant to F. CLL pts (66,6% responded), the majoority of them had unfavourable del 17p.

Disclosures:

No relevant conflicts of interest to declare.

Author notes

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Asterisk with author names denotes non-ASH members.

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