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A controlled study of cyclophosphamide (Cytoxan) therapy in acute leukemia was conducted in 142 children in relapse to previous therapies. An oral regimen, using daily doses of 3mg/kg/day induced remission (complete or good partial) in 31.5% of the group; the intravenous regimen, using 15 mg/kg once weekly, induced similar remission in only 10.2% of the children so treated. All children who attained complete or partial remissions entered the study in a status of moderate disease while those in a more severe status of disease failed to attain satisfactory remissions to either regimen. Bone marrow remissions (A‐1 ratings) were attained in 27.5% of the group treated orally and in only 2.9% of those treated with the intravenous regimen. Leukopenia was the only significant hematologic sign of toxicity with either route of therapy. Signs of inflamation of the urinary tract occurred in approximately 10% of the patients. Nausea and vomiting were much more common with intravenous therapy. Cyclophosphamide, administered orally, is effective for the treatment of acute leukemia for children in early relapse but is not effective in patients in severe relapse to previous therapy.

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