Valganciclovir prevents cytomegalovirus reactivation in patients receiving alemtuzumab-based therapy

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Blood, 15 February 2008, Vol. 111, No. 4, pp. 1816-1819.

Valganciclovir prevents cytomegalovirus reactivation in patients receiving

alemtuzumab-based therapy

O'Brien1, Farhad Ravandi1, Todd Riehl2, Wierda1, Xuelin Huang3,

Tarrand2, O'Neal1, Hagop Kantarjian1, and Keating1

Departments of1 Leukemia, 2 Laboratory Medicine, and 3 Biostatistics and Applied

Mathematics, University of Texas M. D. 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] .