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Blood, 15 February 2008, Vol. 111, No. 4, pp. 1816-1819.
Prepublished online as a Blood First Edition Paper on November 26, 2007; DOI 10.1182/blood-2007-03-080010.
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Submitted March 15, 2007
Accepted October 22, 2007
Valganciclovir prevents CMV reactivation in patients receiving alemtuzumab based therapy
Susan O'Brien*, Farhad Ravandi, Todd Riehl, William Wierda, Xuelin Huang, Jeffrey Tarrand, Brandi O'Neal, Hagop Kantarjian, and Michael Keating
Department of Leukemia, University of Texas - M. D. Anderson Cancer Center, Houston, TX, United States
Department of Laboratory Medicine, University of Texas - M. D. Anderson Cancer Center, Houston, TX, United States
Department of Biostatististics and Applied Mathematics, University of Texas - M. D. Anderson Cancer Center, Houston, TX, United States
* Corresponding author; email: sobrien{at}mdanderson.org.
Alemtuzumab is an immunosuppressive antibody that depletes normal T-cells as well as B-cells. Prophylaxis for herpes virus and pneumocystis carinii is standard with this agent. About 20-25% of patients will experience CMV reactivation. We conducted a randomized trial wherein patients being treated with an alemtuzumab-containing regimen received prophylaxis with either valaciclovir 500 mg orally daily, or valganciclovir 450 mg orally twice daily. The study design planned to enroll 128 patients, but stopping rules for early termination were met. Forty patients were evaluable. Median age was 58 years (range 25-83); median number of prior therapies was 2 (0-10). Diagnoses included CLL (29), T-PLL (3), HCL (1), ATLL (1), marginal zone leukemia (1), LGL leukemia (2), ALL (1), T-cell lymphoma (2). Patients received varying alemtuzumab-containing regimens including single agent (5), or combined with: rituximab (2), pentostatin (6), fludarabine, cyclophosphamide, and rituximab (FCR) (23), or fractionated cyclophosphamide, vincristine, adriamycin, and dexamethasone (Hyper CVAD)(4). Seven of 20 patients enrolled on the valaciclovir arm experienced CMV reactivation. None of the 20 patients randomized to valganciclovir experienced CMV reactivation (p=0.004). In conclusion, this agent was highly effective for prophylaxis of CMV reactivation in patients receiving alemtuzumab. This trial was registered at www.ClinicalTrials.gov as #NCT00562770.
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