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

A Phase II Trial Of Arsenic Trioxide (TRISENOX) In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00193518

Enrollment

Registered

2005-09-19

Start date

2004-04-30

Completion date

2006-04-30

Last updated

2011-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

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 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

Detailed description

Upon determination of eligibility, patients will receive: * Arsenic Trioxide

Interventions

DRUGArsenic Trioxide

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
Overall response rate	—

Secondary

Measure	Time frame
Progression-free survival	—
Toxicity	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026