EUCTR2018-001284-24-IT进行中（未招募）1 期
A Phase 2, Open-label Study of Zanubrutinib (BGB-3111) in Patients with Relapsed or Refractory Marginal Zone Lymphoma - NA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 65
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Each patient eligible to participate in this study must meet all the following criteria:
- •1. Age 18 years or older
- •2. Histologically confirmed diagnosis of MZL including splenic, nodal, and extranodal subtypes (nodal MZL enrollment is capped at 30 patients). Gastric MZL must be H. pylori-negative disease or H. pylori-positive disease that has remained stable, progressed, or relapsed following antibiotic therapy. Patients with a screening serum immunoelectrophoresis result indicating a monoclonal spike must have a possible diagnosis of Waldenström's macroglobulinemia ruled out.
- •3. Previously received one or more lines of therapy including at least one CD20-directed regimen
- •(either as monotherapy or as chemoimmunotherapy) with documented failure to achieve at
- •least PR or documented PD after, the most recent systemic treatment
- •4. Current need for systemic therapy for MZL in the opinion of the investigator
- •5. Availability of archival tissue or consent to obtain fresh tumor tissue sample from an evaluable core or excisional biopsy (approximately 10 to 15 unstained formalin fixed paraffin embedded slides or tissue box).
- •6. Measurable disease by CT or MRI. Measurable disease is defined as = 1 nodal lesion > 1.5 cm in longest diameter and/or = 1 extranodal lesion > 1.0 cm in longest diameter, and lesion(s) measurable in 2 perpendicular diameters. Patients with spleen-only disease are not considered to have measurable disease
- •7. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •8. Life expectancy = 6 months
- •9. Adequate bone marrow function
- •a. Absolute neutrophil count (ANC) = 1,000/mm3 (growth factor use is allowed), except for patients with bone marrow involvement by MZL in which case ANC must be = 750/mm3
- •b. Platelet = 75,000/mm3 (may not be post-transfusion), except for patients with bone marrow involvement by MZL in which case the platelet count must be = 50,000/mm3
- •10. Adequate organ function
- •a. Creatinine clearance = 30 mL/min (as estimated by the Cockcroft-Gault equation or as measured by nuclear medicine scan or 24-hour urine collection)
- •b. Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase and alanine aminotransferase/serum glutamic pyruvic transaminase = 2.5 × upper limit of normal (ULN) unless due to MZL
- •c. Serum total bilirubin < 2.0 × ULN (unless documented Gilbert’s syndrome)
- •11. Female patients of childbearing potential must have a negative pregnancy test at screening and must practice highly effective methods of contraception initiated prior to first dose of study drug, for the duration of the study, and for = 90 days after the last dose of zanubrutinib. These
- •methods are described in Section 4.1
- •12. Male patients are eligible if vasectomized or if they agree to the use of barrier contraception with other methods described above during the study treatment period and for = 90 days after the last dose of zanubrutinib
- •13. Ability to provide written informed consent and can understand and comply with the requirements of the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 37
排除标准
- •Each patient eligible to participate in this study must not meet any of the following exclusion criteria:
- •1. Known transformation to aggressive lymphoma, eg, large cell lymphoma. Clinically suspected transformation will require a biopsy of the suspected area prior to enrollment to confirm absence of transformation
- •2. Clinically significant cardiovascular disease (as defined in Section 4.2)
- •3. Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer
- •4. History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
- •5. History of stroke or intracranial hemorrhage within 180 days before first dose of study drug
- •6. Severe or debilitating pulmonary disease
- •7. Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
- •8. Active fungal, bacterial and/or viral infection requiring systemic therapy
- •9. Known central nervous system involvement by lymphoma
- •10. Underlying medical conditions that, in the investigator’s opinion, will render the administration of study drug hazardous or obscure the interpretation of toxicity or AEs
- •11. Known infection with HIV, or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection (as defined in Section 4.2)
- •12. Major surgery within 4 weeks of the first dose of study drug
- •13. Prior treatment with a Bruton tyrosine kinase (BTK) inhibitor
- •14. Last dose of prior therapy for MZL = 21 days prior to first dose of study drug, with the following additional exclusion requirements:
- •a. Treatment with monoclonal antibody-based therapy within 28 days of first dose of study drug
- •b. Treatment with chimeric antigen receptor T-cell therapy within 180 days of first dose of study drug
- •c. Treatment with any herbal medicine with anti-neoplastic intent within 28 days of first dose of study drug
- •d. Allogeneic hematopoietic stem cell transplantation within 12 months of first dose of study drug
- •15. Any chemotherapy or radiation treatment for non-MZL indications within 21 days of first dose of study drug
- •16. Toxicity from prior anti-cancer therapy that has not recovered to = Grade 1 (except for alopecia, ANC, and platelet count; for ANC and platelet count, see Inclusion criterion 9)
- •17. Pregnant or lactating women
- •18. Vaccination with a live vaccine within 35 days prior to the first dose of study drug
- •19. Ongoing alcohol or drug addiction
- •20. Hypersensitivity to zanubrutinib or any of the other ingredients in zanubrutinib
- •21. Requires ongoing treatment with a strong CYP3A inhibitor or inducer
- •22. Received investigational drug within 30 days prior to first dose of zanubrutinib on this study or plans to receive another investigational drug during this study
研究者
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