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Completed

NCT Number: NCT00193518

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

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

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Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Small Lymphocytic Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

About this study

Upon determination of eligibility, patients will receive:

  • Arsenic Trioxide

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

arsenic trioxide

Drug

Primary outcomes

  1. Overall response rate

Secondary outcomes

  1. Progression-free survival

  2. Toxicity

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • CTI BioPharma

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
May 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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