Clinical Trials

Inclusion Criteria:

• Aged ≥ 18 years old.
• Voluntarily consented to the study.
• WHO classification defined B-lymphoid malignancy with the exception of Burkitt lymphoma/leukemia, plasma cell myeloma, acute lymphoblastic leukemia, lymphoblastic lymphoma, and plasmablastic lymphoma.
• Requirement for treatment in the opinion of the investigator.
• Disease which has relapsed, or is refractory, following at least one line of therapy, with no therapy of higher priority available.
• ECOG performance status of 0-2.
• Adequate hematologic function, as defined by neutrophils ≥ 1.0 x 10^9/L and platelets ≥ 50 x 10^9/L; patients with neutrophils < 1.0 x 10^9/L due to marrow infiltration are allowed to receive growth factors to bring pre-treatment neutrophils to ≥ 1.0 x 10^9/L.
• Adequate renal function, as defined by creatinine clearance of ≥ 50 ml/min (as estimated by the Cockcroft-Gault equation or as measured by nuclear medicine scan or 24 hour urine collection).
• Adequate liver function, as defined by AST and ALT ≤ 3 x ULN, and bilirubin ≤ 1.5 x ULN (unless documented Gilbert's syndrome).
• INR and APTT ≤ 1.5 x ULN.
• Female subjects of childbearing potential and non-sterile males must practice at least one of the following methods of birth control with partner(s) throughout the study and for 90 days after discontinuing study drug: t
  • Total abstinence from sexual intercourse;
  • Double-barrier contraception;
  • IUD;
  • Hormonal contraceptive initiated at least 3 months prior to first dose of study drug.
• Male subjects must not donate sperm from initial study drug administration, until 90 days after drug discontinuation.

Exclusion Criteria:

• Current CNS involvement by disease.
• Current histologically transformed disease.
• Prior BTK inhibitor treatment.
• Allogeneic stem cell transplantation within 6 months, or has active GVHD requiring ongoing immunosuppression.
• Receipt of the following treatment prior to first dose of BGB-3111:
  • Corticosteroids given with anti-neoplastic intent within 7 days;
  • Chemotherapy or radiotherapy within 2 weeks;
  • Monoclonal antibody within 4 weeks.
• Not recovered from toxicity of any prior chemotherapy to grade ≤ 1.
• History of other active malignancies within 2 years of study entry with the exception of:
  • Adequately treated in-situ carcinoma of cervix;
  • Localized basal cell or squamous cell carcinoma of skin'
  • Previous malignancy confined and treated locally (surgery or other modality) with curative intent.
• Uncontrolled systemic infection requiring parenteral anti-microbial therapy.
• Major surgery in the past 4 weeks.
• Known HIV, or active hep B or hep C infection (detected positive by PCR).
• Cardiovascular disease resulting in New York Heart Association function status of ≥ 3.
• Significant active renal, neurologic, psychiatric, hepatic or endocrinologic disease that in the investigator's opinion would adversely impact on his/her participating in the study.
• Inability to comply with study procedures.
• On medications which are CYP3A inhibitors.

• Current CNS involvement by disease.
• Current histologically transformed disease.
• Prior BTK inhibitor treatment.
• Allogeneic stem cell transplantation within 6 months, or has active GVHD requiring ongoing immunosuppression.
• Receipt of the following treatment prior to first dose of BGB-3111:
  • Corticosteroids given with anti-neoplastic intent within 7 days;
  • Chemotherapy or radiotherapy within 2 weeks;
  • Monoclonal antibody within 4 weeks.
• Not recovered from toxicity of any prior chemotherapy to grade ≤ 1.
• History of other active malignancies within 2 years of study entry, with the exception of:
  • Adequately treated in-situ carcinoma of the cervix;
  • Localized basal cell or squamous cell carcinoma of skin;
  • Previous malignancy confined and treated locally (surgery or other modality) with curative intent.
• Uncontrolled systemic infection requiring parenteral anti-microbial therapy.
• Major surgery in the past 4 weeks.
• Known HIV, or active hep B or hep C infection (detected positive by PCR).
• Cardiovascular disease resulting in New York Heart Association function status of ≥ 3.
• Significant active renal, neurologic, psychiatric, hepatic or endocrinologic disease that in the investigator's opinion would adversely impact on his/her participating in the study.
• Inability to comply with study procedures.
• On medications which are CYP3A inhibitors.