Blood, 15 February 2008, Vol. 111, No. 4, pp. 1816-1819.
Valganciclovir prevents cytomegalovirus reactivation in patients receiving
alemtuzumab-based therapy
Susan O'Brien1, Farhad Ravandi1, Todd Riehl2, William Wierda1, Xuelin Huang3,
Jeffrey Tarrand2, Brandi O'Neal1, Hagop Kantarjian1, and Michael Keating1
Departments of1 Leukemia, 2 Laboratory Medicine, and 3 Biostatistics and Applied
Mathematics, University of Texas M. D. Anderson Cancer Center, Houston

Alemtuzumab is an immunosuppressive antibody that depletes normal T cells and B
cells. Prophylaxis for herpes virus and Pneumocystis carinii is standard with
this agent. Approximately 20% to 25% of patients will experience cytomegalovirus
(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 years); median number of prior therapies was 2 (range, 0-10).
Diagnoses included chronic lymphocytic leukemia (29), T-cell prolymphocytic
leukemia (3), hairy cell leukemia (1), adult T-cell leukemia/lymphoma (ATLL)
(1), marginal zone leukemia (1), large granular lymphocyte leukemia (2), acute
lymphoblastic leukemia (1), and T-cell lymphoma (2). Patients received various
alemtuzumab-containing regimens, including single agent (5) or combined with:
rituximab (2), pentostatin (6), fludarabine, cyclophosphamide, and rituximab
(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 = .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 [ClinicalTrials.gov] .




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