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We conducted a randomized, controlled study in southern Colombia to determine if the addition of allopurinol to stibogluconate was superior to stibogluconate alone in the treatment of cutaneous leishmaniasis. Lesions that healed after a 3-month course of therapy and remained so during a 1-year period of follow-up were considered cured. The cure rate for patients treated with stibogluconate was 39%; the addition of allopurinol increased this rate to 71% (P = .005). For the treatment of cutaneous leishmaniasis, the combination of allopurinol and stibogluconate is significantly more effective than is stibogluconate alone. These results support those of other clinical studies in which allopurinol and stibogluconate were shown to be superior to stibogluconate alone. The aggregate data support the use of allopurinol as an inexpensive, orally administered agent that can be used as an adjunct to stibogluconate or, perhaps, other oral agents in the treatment of cutaneous leishmaniasis.

Treatment with FCM results in responses rates of 60% in relapsed or refractory CLL patients. Against this background, we started a trial of FCM in untreated patients diagnosed with CLL younger than 65 yrs. FCM consisted of fludarabine 25 mg/m2 i.v. on days 1 to 3, cyclophosphamide 200 mg/m2 on days 1 to 3, and mitoxantrone 6 mg/m2 i.v. on day 1, given at a 4-week intervals up to six courses. Patients received support with G-CSF and prophylaxis with cotrimoxazole. Response was assessed two months after treatment and included bone marrow and minimal residual disease (MRD) analysis by four-color flow cytometry and PCR. Out the 64 evaluable patients (74% male, median age 58 years), 83% were in advanced (B and C) Binet’s clinical stage and 62% had increased (>20%) ZAP-70 expression. FISH analysis disclosed del(13q) in 25%, +12 in 22%, del(17p) in 10% of cases and del(11q) in 23%. Eighty-three per cent of the patients received the entire planed treatment. Overall response rate was of 88%. MRD-negative CR was obtained in 24%, MRD-positive CR in 23%, nPR 22% and PR 11%. Two out of 14 nPR cases were MRD-negative. Duration of response was 55% at 36 months. Initial parameters associated with CR achievement were the presence of del(17p) (p=0.003), increased serum LDH (P=0.014), and splenomegaly (p=0.04). Hematological toxicity was mild, with grade III-IV neutropenia in 8% of the cases, and moderate infections in 12%. Two patients developed fulminant B hepatitis, one of them dying as a direct consequence of it. In conclusion, in untreated CLL patients, FCM induces a high CR rate, including an important number of MRD negative CR. This places FCM among the most effective regimens for CLL and serves to build up a new immunochemotherapy regimen for CLL (R-FCM) currently under investigation.

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