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)
18 Years
N/A
Both
Non-Hodgkins Lymphoma
Trial Information
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)
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete response rate
Principal Investigator
John D. Hainsworth, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sarah Cannon Research Institute
Authority:
United States: Food and Drug Administration
Study ID:
SCRI LYM 21
NCT ID:
NCT00193466
Start Date:
January 2002
Completion Date:
April 2008
Related Keywords:
- Non-Hodgkins Lymphoma
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Lymphoma
- Lymphoma, Non-Hodgkin
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