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

NCT00193518 | Completed Phase 2

• 1 other identifier: SCRI LYM 33
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall response rate

Secondary Outcomes (2)

• Progression-free survival

• Toxicity

Interventions

Arsenic Trioxide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• CTI BioPharma: collaborator

Study Sites (1)

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds

Study Officials

• John D. Hainsworth, MD

  SCRI Development Innovations, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: April 1, 2004
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: May 3, 2011

Record last verified: 2011-05

Locations

US (1)