Pentostatin, and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia
Pentostatin, and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia
This study aims to assess the rate of complete and overall response using rituximab and
 pentostatin with and without cyclophosphamide, to monitor and assess toxicity of this
 regimen, and to determine the overall and progression-free survival in CLL patients
Rationale: Research indicates that both cyclophosphamide and pentostatin work synergistically
 against cancer cells and have a high response rate against chronic lymphocytic leukemia (CLL)
 without creating severe side effects in patients. In addition, studies have shown that
 rituximab, a therapy that targets the immune system, has the highest efficacy against CLL and
 the lowest toxicity rate when compared with other immunotherapy drugs. Studies also show that
 rituximab enhances the efficacy of the chemotherapy agents cyclophosphamide and pentostatin.
 This study offers the combination of immunotherapy with two promising chemotherapy agents
 against CLL.

 Purpose: This study is evaluating the efficacy and safety of combination treatment with
 cyclophosphamide, pentostatin, and rituximab in patients with CLL. Several tests evaluating
 the genetic and molecular components of CLL will also be performed. Some of these tests will
 be conducted before, during, and after treatments to assess changes resulting from the study
 drugs. Each patient's outcome will be assessed in relation to various aspects of their genes.
Inclusion Criteria:

 -  Diagnosis of B-CLL (no mantle cell)

 -  Must have active disease

 -  Age >=18 yo

 -  ECOG 0-3

 -  No radiation or surgery <4 weeks

 Exclusion Criteria:

 -  Any of the following comorbid conditions:

 -  New York Heart Association Class III or IV heart disease

 -  Recent myocardial infarction (<1 month)

 -  Uncontrolled infection

 -  Active infection with the human immunodeficiency virus (HIV/AIDS) as further
 severe immunosuppression with this regimen may occur.

 -  Pregnant or nursing women

 -  Men or women of child bearing potential must use adequate contraception.

 -  Active primary malignancy requiring treatment or limits survival to ≤2 years.

 -  Any radiation therapy ≤4 weeks prior to study entry.

 -  Any major surgery ≤4 weeks prior to study entry.