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Chronic lymphatic leukemia (CLL), incurable by standard treatments, may be potentially cured by allogeneic hematopoietic stem cell transplantation. Since CLL affects predominantly older people, there is a need for some low-toxicity conditioning with, on the other hand, strong antileukemic activity. Since there are very encouraging results with busulfan + fludarabine conditionings in myeloid malignancies and since the clinical study with the combination treatment with chlorambucil and fludarabine was stopped prematurely for myelotoxicity, we hypothesized that this chlorambucil + fludarabine combination would have the potential as a good conditioning for high-risk lymphoid malignancies. The aim of this study was to test the chlorambucil + fludarabine combination in vivo (in rats) for toxicity. Male Wistar rats were used in all experiments. First, the maximum tolerated dose (MTD) of each drug was tested. For fludarabine, doses of 0.75-60 mg/kg/day, and for chlorambucil, doses of 0.15-50 mg/kg/day were used, all administered for five days. Then, the combination treatment was tested: (1) fludarabine and chlo -

Chlorambucil and fludarabine as a new pre-transplant conditioning for patients with chronic lymphocytic leukemia: results of in vivo experiments