Title

Using Pentostatin, In Combination with Chlorambucil and Prednisone, to Treat B-chronic Lymphocytic Leukemia (A Phase I/II Study)

Sponsor

Eastern Cooperative Oncology Group www.ecog.org 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.

Results

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.

Start Date

June 8, 1989

Stop Date

July 2,1992

Number of Participating Patients

55 Phase I

38 Phase II

Eligibility Requirements

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.

Study Design

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.

Side Effects

Severe infections were experienced by 31 percent of patients, including pneumonia, fungal infection, urinary tract infection and herpes zoster.

References

Oken MM, Lee S, Kay NE, Knopse WH, Cassileth PA. Pentostatin, Chlorambucil, and Prednisone for the Treatment of Chronic Lymphocytic Leukemia: A Phase I/II Study of the Eastern Cooperative Oncology Group: Study E1488. Leuk Lymphoma 2004 Jan;45(1):79-84. (E1488) [Manuscript published 1/15/2004]

National Cancer Institute Patient Summary

Not Available.

Reviewed by

Martin Oken, MD, Robert Catalano, PharmD, Cheryl Rutledge, BSN