Arsenic Trioxide in Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- Overall response rate
- 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) |
Upon determination of eligibility, patients will receive:
- Arsenic Trioxide
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, Tennessee | |
| Tennessee Oncology, PLLC | |
| Nashville, Tennessee, United States, 37023 | |
| Principal Investigator: | John D. Hainsworth, MD | Sarah Cannon Research Institute |
More Information
No publications provided
| Responsible Party: | SCRI Oncology Research Consortium, SCRI |
| ClinicalTrials.gov Identifier: | NCT00193518 History of Changes |
| Other Study ID Numbers: | SCRI LYM 33 |
| Study First Received: | September 12, 2005 |
| Last Updated: | May 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphoma Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Arsenic trioxide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013