Using Pentostatin, In Combination with Chlorambucil and Prednisone, to Treat B-chronic Lymphocytic Leukemia (A Phase I/II Study)
Eastern Cooperative Oncology Group through the NCI-sponsored Cancer Cooperative Group Program
Purpose of the Study
To determine the dose of pentostatin that could be combined with chlorambucil and prednisone to treat chronic lymphocytic leukemia and to evaluate the safety and effectiveness of the resulting treatment.
A dose of 2mg/sq M was arrived at after higher doses proved unsuitable. The combination of pentostatin, chlorambucil and prednisone was a highly effective treatment for B-chronic lymphocytic leukemia. It yielded responses in 87 percent of previously untreated patients with 45 percent of all patients showing a complete response. However, it cannot be recommended in the dose studied, because of an unacceptable number (31 percent) of severe infections experienced by patients during the study.
June 8, 1989
Number of Participating Patients
55 Phase I
38 Phase II
Patients who participated in this study had active B-chronic lymphocytic leukemia. Patients had not received prior treatment for this disease and had normal kidney and liver function.
Pentostatin was administered in three different doses, along with a standard dose of chlorambucil and prednisone at the beginning of treatment. The higher doses of Pentostatin did not increase the effectiveness of the treatment, so the second phase of the study tested only the lower dose.
Severe infections were experienced by 31 percent of patients, including pneumonia, fungal infection, urinary tract infection and herpes zoster.