SHS_492312 PAGJ CACT 15262

A Phase II Study Using ACP-196 in Patients With Relapsed/Refractory and Treatment Naive Deletion 17p CLL/SLL

This study is to determine the response to ACP-196 in patient with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Inclusion Criteria:

•Men and women 18 years of age and older with histologically confirmed disease.
•Active disease as defined by at least one of the following (IWCLL consensus criteria):
Weight loss ≥10% within the previous 6 months
Extreme fatigue
Fevers of greater than 100.5ºF for ≥2 weeks without evidence of infection
Night sweats for more than one month without evidence of infection
Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia
Massive or progressive splenomegaly
Massive nodes or clusters or progressive lymphadenopathy
Progressive lymphocytosis with an increase of >50% over a 2 month period, or an anticipated doubling time of less than 6 months
Compensated autoimmune hemolysis
•Relapsed/Refractory CLL/SLL or treatment naïve patients
•Agreement to use acceptable methods of contraception during the study and for 30 days after the last dose of study drug if sexually active and able to bear or beget children.
•Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty and serial biopsies.
•Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations).

Exclusion Criteria:

•Radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or investigational products in the last 4 weeks.
•Richter's transformation. Autoimmune hemolytic anemia or thrombocytopenia requiring steroid therapy. Impaired hepatic function
Phase II
John Pagel, M.D.
Acerta Pharma BV
Neil Bailey
  • Swedish Medical Center