A Study of the Safety and Drug/Body Interactions of BGB-3111 for Patients with B-Cell Lymphoid Malignancies

Overview

  • Study type

    Interventional
  • Study phase

    I
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 16-002135
    • Scottsdale/Phoenix, Arizona: 16-002135
    • Jacksonville, Florida: 16-002135
    NCT ID: NCT02343120
    Sponsor Protocol Number: BGB-3111-AU-003

About this study

The purpose of this study is to evaluate the safety, tolerability, drug/body interactions, and treatment effects of a new drug known as BGB-3111 in patients who have B-cell lymphoid malignancies.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Patrick Johnston, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Patrick Johnston, M.D., Ph.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Patrick Johnston, M.D., Ph.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20301416

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