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A Pilot Two-Step Phase II Study of the Oral Gold Compound Auranofin in Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)/Prolymphocytic Lymphoma (PLL)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma, Leukemia, Prolymphocytic

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Trial Information

A Pilot Two-Step Phase II Study of the Oral Gold Compound Auranofin in Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)/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 2 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

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:

Response Rate

Outcome Time Frame:

24 months

Safety Issue:

Yes

Principal Investigator

Suman Kambhampati, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas

Authority:

United States: Food and Drug Administration

Study ID:

12838

NCT ID:

NCT01419691

Start Date:

September 2011

Completion Date:

September 2014

Related Keywords:

  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Lymphoma
  • Leukemia, Prolymphocytic
  • auranofin
  • chronic lymphocytic leukemia
  • relapsed
  • refractory
  • CLL
  • SLL
  • PLL
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, Prolymphocytic
  • Lymphoma

Name

Location

University of Kansas Cancer CenterKansas City, Kansas  66160