Pentostatin, and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Phase II Trial of Pentostatin, and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia (CLL)

Conditions
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B-Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Drug: Pentostatin
* Drug: Rituximab
* Drug: Cyclophosphamide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pentostatin|2 mg/m2 IV over 30 minutes in 250 mL NS on day 1 during cycles 1-6.|
|Drug: Rituximab|For the first week only: Day 1 of therapy 100 mg IV over 4 hours. Day 3 of therapy 375 mg/m2 IV at 50 mg/hr and increase by 100 mg/hr at 30-minute intervals to a maximum of 400 mg/hr. Day 5 of therapy 375 mg/m2 IV at 100 mg/hr for the first 15 minutes the remainder goes in at 45 minutes. The remaining weeks 375 mg/m2 will be repeated as a single IV infusion Day 1 of Week 4, 7, 10, 13 and 16 during cycles 2-6.|
|Drug: Cyclophosphamide|600 mg/m2 IV in 250 mL NS over 30 minutes on day 1 cycles 1-6|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the rate of complete and overall response using rituximab and pentostatin with and without cyclophosphamide. | For this evaluation, patients will be classified as complete responders if either of the following types of response are documented CCR (Clinically based complete remission) denotes NED (No Evidence of Disease) based on baseline clinical parameters. CR denotes CCR and, in bone marrow, no nodules and <30% lymphocytes. | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To monitor and assess toxicity of this regimen. |  | up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Previously Untreated