Trial | NCT01419691  Report issue

Title

Phase I and II Study of Auranofin in Chronic Lymphocytic Leukemia (CLL)
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)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    auranofin ...

  • Study Participants

    15
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).
Study Started
Sep 30
2011
Primary Completion
Sep 30
2015
Study Completion
Sep 30
2015
Last Update
Jan 18
2016
Estimate

Drug auranofin

6 mg twice a day for a total of 12 mg total daily dose

  • Other names: Ridaura

Phase 2 Dose Experimental

Auranofin 6 mg orally in the morning / 6 mg orally in the evening

Criteria 

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
No Results Posted