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

NCT ID: NCT00193518

Last Updated: 2011-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2006-04-30

Brief Summary

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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

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Upon determination of eligibility, patients will receive:

* Arsenic Trioxide

Conditions

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Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Arsenic Trioxide

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CTI BioPharma

INDUSTRY

Sponsor Role collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role lead

Responsible Party

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SCRI

Principal Investigators

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John D. Hainsworth, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

Locations

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Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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SCRI LYM 33

Identifier Type: -

Identifier Source: org_study_id

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