Leukemia Clinical Trials

‣ Subjects who meet each of the following inclusion criteria are eligible to participate in this study:

• Age ≥18 years old.

• Diagnosis as relapsed/refractory chronic lymphocytic leukemia/ small lymphocytic lymphoma according to the IWCLL NCI-WG guidelines revised in 2008.

• Through radiological assessment, subjects with a lymph node length ≥ 10 cm require prior approval from the sponsor before enrollment.

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -1.

• QTcF interval ≤450ms in males, and ≤470ms in females.

• Adequate bone marrow function independent of growth factor and transfusion.

• Adequate renal and liver function.

• Willingness by males, female patients of child bearing potential, and their partners to use contraception by effective methods throughout the treatment period and for at least three months following the last dose of study drug.

• Pregnancy test results of serum samples obtained within 14 days before the first study drug administration in fertile female subjects were negative; If the serum pregnancy test results obtained are\> 7 days from the first administration, urine sample obtained before the first study dose of study drug must be negative.

⁃ Male subjects must avoid sperm donation throughout the treatment period and for at least three months following the last dose of study drug.

⁃ Ability to understand and willingness to sign a written informed consent form approved by EC committee (the consent form must be signed by the patient prior to any screening or study-specific procedures).

⁃ Willingness and ability to comply with study procedures and follow-up examination.