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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00193518
First Posted: September 19, 2005
Last Update Posted: May 3, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
CTI BioPharma
Information provided by:
SCRI Development Innovations, LLC
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Of Arsenic Trioxide (TRISENOX) In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Overall response rate

Secondary Outcome Measures:
  • Progression-free survival
  • Toxicity

Estimated Enrollment: 41
Study Start Date: April 2004
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Upon determination of eligibility, patients will receive:

  • Arsenic Trioxide
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193518


Locations
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
CTI BioPharma
Investigators
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
  More Information

Responsible Party: SCRI Oncology Research Consortium, SCRI
ClinicalTrials.gov Identifier: NCT00193518     History of Changes
Other Study ID Numbers: SCRI LYM 33
First Submitted: September 12, 2005
First Posted: September 19, 2005
Last Update Posted: May 3, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Arsenic trioxide
Antineoplastic Agents