Overview
A Phase I/II Dose-Escalation and Expansion Study Of The Selective PKC-Β Inhibitor MS-553 In Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Eligibility
Inclusion Criteria:
To be eligible for inclusion in the primary escalation and expansion cohort 1 in this
study, patients must meet all of the following criteria:
1. Age 18 years or older
2. Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL):
1. History of histologically documented CLL or SLL that meets IWCLL diagnostic
criteria according to the 2008 guidelines, and
2. Indication for treatment as defined by the 2008 IWCLL guidelines, or the need for
disease reduction prior to allogeneic transplantation
Exclusion Criteria:
Patients who meet any of the following criteria are not eligible for the primary escalation
and expansion cohorts of this study:
1. Current or past transformation of CLL/SLL to prolymphocytic leukemia (PLL),
non-Hodgkin lymphoma, or Hodgkin lymphoma aggressive lymphoma outlined in the
inclusion criteria for the optional cohort.
2. Active and uncontrolled autoimmune cytopenia(s)
3. Any of the following prior therapies within 14 days prior to cycle 1, day 1:
1. Major surgery
2. Corticosteroids greater than 20 mg / day prednisone (or equivalent), unless used
by inhalation or topical route, or unless necessary for premedication before
iodinated contrast dye, or for autoimmune hemolytic anemia
3. Cytotoxic chemotherapy or biologic therapy, excepting BCR pathway kinase
inhibitors for which no wash out is required (but must be stopped before cycle 1
day 1)