Arsenic Trioxide in Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

SCRI Development Innovations

Status and phase

Completed

Phase 2

Conditions

Small Lymphocytic Lymphoma

Chronic Lymphocytic Leukemia

Treatments

Drug: Arsenic Trioxide

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00193518

SCRI LYM 33

Details and patient eligibility

About

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 malignancies. Since arsenic trioxide produces mild to moderate myelosuppression and is not as immunosuppressive as other available agents, it may be an additional treatment option for CLL/SLL. This study will evaluate the feasibility and toxicity of arsenic trioxide in patients with relapsed or refractory CLL/SLL

Full description

Upon determination of eligibility, patients will receive:

Arsenic Trioxide

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.