Status:
COMPLETED
Arsenic Trioxide in Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
CTI BioPharma
Conditions:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Additional active agents are needed to further improve the treatment of patients with CLL/SLL. Increasing information exists regarding the activity of arsenic trioxide in other hematologic malignancie...
Detailed Description
Upon determination of eligibility, patients will receive: * Arsenic Trioxide
Eligibility Criteria
Inclusion
- To be included in this study, you must meet the following criteria:
- Histologically proven B-cell CLL/SLL.
- Must have had a minimum of 1 and a maximum of 3 previous systemic regimens
- Must have progressive CLL/SLL
- Measurable or evaluable disease
- ECOG performance status 0, 1, or 2
- Age \> 18 years.
- Patients with cytopenias caused by bone marrow involvement are eligible
- All patients must give written informed consent prior to entering this study.
Exclusion
- You cannot participate in this study if any of the following apply to you:
- Unstable active infection on the basis of neutropenia
- Previous severe opportunistic infections
- Severe immune mediated anemia or thrombocytopenia
- Serious underlying medical conditions
- Brain metastases or meningeal involvement
- History of other neoplasms
- Significant underlying heart dysfunction
- Women who are pregnant or
- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00193518
Start Date
April 1 2004
End Date
April 1 2006
Last Update
May 3 2011
Active Locations (1)
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1
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023