Frontline chemoimmunotherapy with fludarabine, cyclophosphamide, alemtuzumab, and rituximab for high-risk chronic lymphocytic leukemia

1. Sameer A. Parikh1,
2. Michael J. Keating1,
3. Susan O'Brien1,
4. Xuemei Wang2,
5. Alessandra Ferrajoli1,
6. Stefan Faderl1,
7. Jan Burger1,
8. Charles Koller1,
9. Zeev Estrov1,
10. Xavier Badoux1,
11. Susan Lerner1, and
12. William G. Wierda1

+ Author Affiliations

1. Departments of ¹Leukemia and
2. ²Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston, TX

1. Presented in abstract form at the American Society of Hematology annual meetings of December 8-11, 2007, Atlanta, GA; December 6-9, 2008, San Francisco, CA; and December 5-8, 2009, New Orleans, LA.

 

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Abstract

Frontline chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab (FCR) is associated with superior overall survival (OS) for patients with chronic lymphocytic leukemia (CLL). Alemtuzumab (A) was added to FCR (CFAR) in a phase 2 trial for high-risk untreated patients < 70 years with serum β-2 microglobulin (β2M) ≥ 4 mg/L. Sixty patients were enrolled; median age was 59 years (range, 42-69); 75% were male; median β2M was 5.1 mg/L (range, 4-11.6); and 51% were Rai III-IV. Complete remission (CR) was achieved in 70%, partial remission (PR) in 18%, nodular PR in 3%, for an overall response of 92%. Of 14 patients with 17p deletion, CR was achieved by 8 (57%). Of 57 BM samples evaluated by 3-color flow cytometry at the end of treatment, 41 (72%) were negative for residual disease. Grade 3-4 neutropenia and thrombocytopenia occurred with 33% and 13% courses, respectively. The median progression-free survival was 38 months and median OS was not reached. In conclusion, CFAR is an active frontline regimen for high-risk CLL. Response rates and survival are comparable with historic high-risk FCR-treated patients. CFAR may be a useful frontline regimen to achieve CR in patients with 17p deletion before allogeneic stem cell transplantation.

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Frontline chemoimmunotherapy with fludarabine, cyclophosphamide, alemtuzumab, and rituximab for high-risk chronic lymphocytic leukemia