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A Phase II Study of Pentostatin with Cyclophosphamide and Rituximab for Previously Untreated Patients with Chronic Lymphocytic Leukemia

[Protocol 05-051]


Full Title :
A PHASE II STUDY OF PENTOSTATIN WITH CYCLOPHOSPHAMIDE AND RITUXIMAB FOR PREVIOUSLY UNTREATED PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
Purpose :

The purpose of this study is to see how well three drugs (pentostatin, cyclophosphamide, and rituximab) work together in patients with chronic lymphocytic leukemia (CLL) who have not yet been treated. All three drugs are active against CLL.

These three drugs have been evaluated together in patients who had already been treated for CLL. The three-drug combination was safe, and most patients responded to the treatment.

The current standard initial treatment for patients with CLL is a single drug -- either chlorambucil or fludarabine. In general, about 35 to 65 percent of patients respond to standard therapy. But most of these responses are partial, and typically only 5 to 20 percent of patients will achieve a complete response.

Drug combinations have been tested before in patients with CLL and do produce higher rates of response, but at the price of more side effects than standard single-drug therapy. Doctors hope that by combining these three particular drugs, this regimen will not only be more active against untreated CLL and produce a large number of responses (and complete responses), but may be associated with fewer side effects than other combination treatments.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of CLL that has not yet been treated.
  • Patients must be age 18 or older.

For more information and to see if you are eligible for this study, please contact Dr. Mark Weiss at 212-639-5827.

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