| Inclusion Criteria: | 1) Subject must be >/= 18 years of age.
2) Arm A - Relapsed or refractory CLL/SLL Subject requires treatment in the opinion of the investigator. Subject must have relapsed following or be refractory to standard treatments such as fludarabine based regimens (F, FC, FR, FCR) or alkylator (chlorambucil, bendamustine) based regimens. In addition, the subject is unable to tolerate other available therapies or no other therapies are available. or Arm B - Relapsed or refractory non-Hodgkin lymphoma Subject must have histologically documented diagnosis of a non- Hodgkin lymphoma as defined in the World Health Organization (WHO) classification scheme, except as noted in Exclusion Criteria. Subject must have relapsed following or be refractory to standard treatments such as R-CHOP, RCVP, or fludarabine based regimens. In addition, there are no other curative options, and the subject has exhausted options that would be considered standard of care. Subjects with other lymphoproliferative diseases can be considered.
3) Subject has an ECOG performance score of </= 1.
4) Subject must have adequate bone marrow independent of growth factor support per local laboratory reference range at Screening as follows: ● Absolute Neutrophil Count (ANC) >/= 1000/micro L; ○ An exception is for subjects with an ANC < 1000/micro L and bone marrow heavily infiltrated with underlying disease (approximately 80% or more) may use growth factor to achieve the ANC eligibility criteria per discussion with the Abbott medical monitor; ● Platelets >/= 50,000/mm3 (entry platelet count must be independent of transfusion within 14 days of Screening); ● Hemoglobin >/= 9.0 g/dL.
5) Subject must have adequate coagulation, renal, and hepatic function, per laboratory reference range at Screening as follows: aPTT and PT not to exceed 1.2 × ULN; Calculated creatinine clearance >/= 50 mL/min; AST and ALT </= 3.0 × the upper normal limit (ULN) of institution's normal range; Bilirubin </= 1.5 × ULN. Subjects with Gilbert's Syndrome may have a bilirubin > 1.5 × ULN, per discussion between the investigator and Abbott medical monitor.
6) Female subjects must be surgically sterile, postmenopausal (for at least 1 year), or have negative results for a pregnancy test performed as follows: ● At Screening on a serum sample obtained within 14 days prior to the first study drug administration, and ● Prior to dosing on a urine sample obtained on Week 1 Day –3 (dose escalation phase) or Week 1 Day 1 (expanded safety cohort) if it has been > 7 days since obtaining the serum pregnancy test results.
7) All female subjects not surgically sterile or postmenopausal (for at least 1 year) and non-vasectomized male subjects must practice at least one of the following methods of birth control: ● Total abstinence from sexual intercourse (minimum one complete menstrual cycle); ● A vasectomized partner; ● Hormonal contraceptives (oral, parenteral, transdermal, or vaginal ring) for at least 3 months prior to study drug administration; ● Double-barrier method (including condoms plus diaphragm or vaginal cup with spermicide, contraceptive sponge, jellies or cream).
8) Subject must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
9) NHL subjects who have a history of an autologous stem cell transplant (e.g., bone marrow) must be > 6 months post transplant (prior to the first dose of study drug) and have adequate bone marrow independent of any growth factor support (with the exception of subjects with bone marrow that is heavily infiltrated with underlying disease [80% or more] who may use growth factor support to achieve ANC eligibility criteria), per laboratory reference range at Screening as follows: ● Absolute Neutrophil count (ANC) >/= 1,500/µL; ● Platelets >/= 75,000/mm3 (entry platelet count must be independent of transfusion within 14 days of Screening; ● Hemoglobin >/= 10.0 g/dL |