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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Arsenic Trioxide

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Tennessee Oncology, PLLC

Outcomes

Primary Outcome Measures

Overall response rate

Secondary Outcome Measures

Progression-free survival

Toxicity

Full Information

NCT ID

NCT00193518

First Posted

September 12, 2005

Last Updated

May 2, 2011

Sponsor

SCRI Development Innovations, LLC

Collaborators

CTI BioPharma

1. Study Identification

Unique Protocol Identification Number

NCT00193518

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

April 2004 (undefined)

Primary Completion Date

April 2006 (Actual)

Study Completion Date

April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

SCRI Development Innovations, LLC

Collaborators

CTI BioPharma

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

41 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Arsenic Trioxide

Primary Outcome Measure Information:

Title

Overall response rate

Secondary Outcome Measure Information:

Title

Progression-free survival

Title

Toxicity

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John D. Hainsworth, MD

Organizational Affiliation

SCRI Development Innovations, LLC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tennessee Oncology, PLLC

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37023

Country

United States

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial