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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Sarah Cannon Research Institute Cell Therapeutics
Information provided by:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00193518

Purpose

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

Condition	Intervention	Phase
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma	Drug: Arsenic Trioxide	Phase II

MedlinePlus related topics: Arsenic Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma

Drug Information available for: Arsenic trioxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Trial Of Arsenic Trioxide (TRISENOX) In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:

Overall response rate

Secondary Outcome Measures:

Progression-free survival
Toxicity

Estimated Enrollment:	41
Study Start Date:	April 2004

Detailed Description:

Upon determination of eligibility, patients will receive:

Arsenic Trioxide

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193518

Locations

United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023

Sponsors and Collaborators

Sarah Cannon Research Institute

Cell Therapeutics

Investigators

Principal Investigator:

John D. Hainsworth, MD

Sarah Cannon Research Institute

More Information

Study ID Numbers:	SCRI LYM 33
Study First Received:	September 12, 2005
Last Updated:	October 15, 2007
ClinicalTrials.gov Identifier:	NCT00193518
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Chronic lymphocytic leukemia
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, B-cell, chronic
Arsenic trioxide
Lymphoproliferative Disorders
Leukemia, B-Cell
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009