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Closed (no longer recruiting)Last updated: 22 January 2024

BGB-3111_001: This phase I trial is evaluating an oral drug (BGB-3111) in combination with another drug (obinutuzumab) for the treatment of B-Cell Non Hodgkin LymphomaA Phase 1b Study to Assess Safety, Tolerability and Antitumor Activity of the Combination of BGB 3111 With Obinutuzumab in Subjects With B-Cell Lymphoid Malignancies

Clinical summary

Summary

This study is evaluating the safety and preliminary efficacy of BGB-3111 in combination with obinutuzumab in subjects with B-cell lymphoid malignancies.

Conditions

This trial is treating patients with B-Cell Non Hodgkin Lymphoma.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

Trial Acronym

BGB-3111_001

More information

Trial Identifiers

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Trial sponsor

BeiGene Australia Pty Ltd

Scientific Title

A Phase 1b Study to Assess Safety, Tolerability and Antitumor Activity of the Combination of BGB 3111 With Obinutuzumab in Subjects With B-Cell Lymphoid Malignancies

Eligibility

Inclusion

  • Aged ≥18 years, able and willing to provide written informed consent and to comply with the study protocol.

  • Laboratory parameters as specified below:

    • Hematologic: Platelet count >40x10^9/liter (L) (may be post-transfusion); absolute neutrophil count >1.0x10^9/L (growth factor use is allowed to bring pre-treatment neutrophils to >1.0x10^9 cells/L if marrow infiltration is involved).
    • Hepatic: Total bilirubin <3 x upper limit normal (ULN); and aspartate aminotransferase and alanine transaminase ≤3 x ULN.
    • Renal: Creatinine clearance ≥50 milliliters/minute (as estimated by the Cockcroft Gault equation or as measured by nuclear medicine scan or 24-hour urine collection); participants requiring hemodialysis will be excluded.
  • Anticipated survival of at least 6 months.
  • Eastern Cooperative Oncology Group performance status of 0 to 2.
  • Female participants of childbearing potential and non-sterile males must have agreed to practice at least one of the following methods of birth control with partner(s) throughout the study and for ≥3 months after discontinuing zanubrutinib or ≥18 months following obinutuzumab treatment, whichever was longer: total abstinence from sexual intercourse, double barrier contraception, intra uterine device or hormonal contraceptive initiated at least 3 months prior to first administration of study drug.
  • Male participants must have not donated sperm from first study drug administration, until 3 months after zanubrutinib discontinuation or 18 months following obinutuzumab treatment, whichever is longer.

Exclusion

  • Known central nervous system lymphoma or leukemia.
  • Known prolymphocytic leukemia or history of, or currently suspected, Richter's syndrome.
  • Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.
  • History of significant cardiovascular disease.
  • Severe or debilitating pulmonary disease.
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy.
  • Prior Bruton tyrosine kinase inhibitor treatment.
  • Used medications which were strong cytochrome P450 (CYP) 3A inhibitors and strong CYP3A inducers.
  • Vaccination with a live vaccine within 28 days of the initiation of treatment.
  • Allogeneic stem cell transplantation within 6 months, or had active graft versus host disease requiring ongoing immunosuppression.
  • Receipt of the following treatment prior to first administration of zanubrutinib, corticosteroids given with anti-neoplastic intent within 7 days, chemotherapy or radiotherapy within 3 weeks, monoclonal antibody within 4 weeks.
  • Participated in any investigational drug study within 28 days of study entry, or not recovered from non-hematologic toxicity of any prior chemotherapy up to ≤ Grade 1 (except for alopecia).
  • History of other active malignancies within 2 years of study entry.
  • Major surgery in the past 4 weeks.
  • Active symptomatic fungal, bacterial and/or viral infection including evidence of infection with human immunodeficiency virus, human T cell lymphotropic virus seropositive status.
  • Inability to comply with the study procedures.
  • Pregnant or nursing women.
  • Any illness or condition that in the opinion of the investigator may have affected the safety of treatment or evaluation of any study's endpoints.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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