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


Phase 2
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

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Trial Information

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


Upon determination of eligibility, patients will receive:

- Arsenic Trioxide


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Principal Investigator

John D. Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI LYM 33

NCT ID:

NCT00193518

Start Date:

April 2004

Completion Date:

April 2006

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma

Name

Location

Tennessee Oncology, PLLCClarksville, Tennessee  37043