Last updated on June 2019

Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Relapsed/Refractory B-cell Malignancies
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Aged 18 years, voluntarily consented to the study.
  2. WHO classification defined B-lymphoid malignancy, with the exception of Burkitt lymphoma/leukemia, plasma cell myeloma, acute lymphoblastic leukemia, lymphoblastic lymphoma, and plasmablastic lymphoma.
  3. Requirement for treatment in the opinion of the investigator.
  4. Disease which has relapsed, or is refractory, following at least one line of therapy, with no therapy of higher priority available.
  5. ECOG performance status of 0-2.
  6. 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.
  7. 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).
  8. Adequate liver function, as defined by AST and ALT 3 x ULN, and bilirubin 1.5 x ULN (unless documented Gilbert's syndrome).
  9. INR and APTT 1.5 x ULN.
  10. 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: total abstinence from sexual intercourse, double-barrier contraception, IUD or hormonal contraceptive initiated at least 3 months prior to first dose of study drug.
  11. Male subjects must not donate sperm from initial study drug administration, until 90 days after drug discontinuation.

Exclusion Criteria:

  1. Current CNS involvement by disease
  2. Current histologically transformed disease.
  3. Prior BTK inhibitor treatment.
  4. Allogeneic stem cell transplantation within 6 months, or has active GVHD requiring ongoing immunosuppression.
  5. 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.
  6. Not recovered from toxicity of any prior chemotherapy to grade 1.
  7. History of other active malignancies within 2 years of study entry, with exception of (1) adequately treated in-situ carcinoma of cervix; (2) localized basal cell or squamous cell carcinoma of skin; (3) previous malignancy confined and treated locally (surgery or other modality) with curative intent.
  8. Uncontrolled systemic infection requiring parenteral anti-microbial therapy.
  9. Major surgery in the past 4 weeks.
  10. Known HIV, or active hep B or hep C infection (detected positive by PCR).
  11. Cardiovascular disease resulting in New York Heart Association function status of 3.
  12. 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.
  13. Inability to comply with study procedures.
  14. On medications which are CYP3A inhibitors.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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