Rituximab and Fludarabine Followed by CAMPATH-1H in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Study Overview
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Brief Summary
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In this multicenter trial, we will investigate the use of fludarabine plus rituximab, followed by Campath-1H, in previously untreated patients with CLL/SLL. Patients who are elderly, or who are considered unlikely to tolerate this combination therapy well, will receive single agent rituximab followed by Campath-1H.

Detailed Description
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Upon determination of eligibility, all patients will receive: Fludarabine + Rituximab + CAMPATH-1H Patients who are judged by the investigator not to be candidates for fludarabine due to advanced age, marginal performance status or coexistent medical conditions will receive rituximab alone followed by CAMPATH-1H.

Official Title
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Phase II Trial of Rituximab/Fludarabine Followed by CAMPATH-1H in the First-Line Treatment of Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Conditions
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Non-Hodgkins Lymphoma

Intervention / Treatment
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* Drug: Rituximab
* Drug: Fludarabine
* Drug: CAMPTH-1H


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be included in this study, you must meet the following criteria: Histologically proven B-cell CLL/SLL Positive staining for CD20 antigen No systemic chemotherapy. Measurable or evaluable disease Able to perform activities of daily living with minimal assistance Age > 18 years Life expectancy > 12 weeks Adequate liver and kidney function Must be accessible for treatment and follow-up Must give written informed consent prior to entering this study. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Female pregnant or lactating Unstabilized active infection on the basis of neutropenia History of previous severe opportunistic infections Serious underlying medical conditions Central nervous system involvement History of other neoplasms, either active or treated within five years Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rituximab|nan|
|Drug: Fludarabine|nan|
|Drug: CAMPTH-1H|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular complete response rate |  |  | 
| Progression free survival |  |  | 
| Overall toxicity |  |  |