Phase I and II Study of Auranofin in Chronic Lymphocytic Leukemia (CLL)
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2011 |
| End Date: | September 2015 |
A Phase I Phase II Two-Step Study of the Oral Gold Compound Auranofin in Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL)/ Prolymphocytic Lymphoma (PLL)
The purpose of this study is to evaluate the safety and effectiveness of auranofin to treat
patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or
prolymphocytic lymphoma (PLL).
patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or
prolymphocytic lymphoma (PLL).
Inclusion Criteria:
- histologically confirmed B-cell chronic lymphocytic leukemia (CLL), small lymphocytic
lymphoma (SLL), prolymphocytic leukemia arising from CLL/SLL or Richter's
transformation according to WHO criteria who require therapy based on the 2008
revised IWCLL criteria.
- Relapsed or refractory disease after receiving at least 1 prior therapy for CLL
- At least 18 years old; ECOG status of 1 or less; life expectancy 2 months or greater
- Adequate organ and marrow function (total bilirubin less than 1.5x IULN; ALT less
than 2x IULN; serum creatinine less than 1.5x ULN)
Exclusion Criteria:
- have had chemotherapy, radiotherapy or immunotherapy within 4 weeks prior to entering
study
- have not recovered from AEs due to agents administered more than 4 weeks prior
- receiving any other investigational agent
- known second malignancy that limits survival to less than 2 years
- known HIV positive
- uncontrolled intercurrent illness
- pregnant or breastfeeding
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