EUCTR2018-001701-82-GR进行中（未招募）1 期
Open-label, Single-Arm, Phase 2 Study of Oral HDAC-inhibitor Abexinostat in Patients with Relapsed or Refractory Follicular Lymphoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 139
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 must meet all of the following criteria to be enrolled in this study:
- •1. Is male or female aged 18 years or older
- •2. Is able to understand and voluntarily sign an informed consent document before any study related assessments/procedures are conducted
- •3. Has histologically confirmed Grade 1, 2, or 3a follicular lymphoma
- •4. Has undergone at least 3 prior systemic lines of therapy for their follicular lymphoma, which included an anti-CD20 antibody and cytotoxic therapy
- •5. Has follicular lymphoma that has relapsed after (progressed after 6 months from the start of therapy) or is refractory to the last line of therapy (no response or progression within 6 months from the start of therapy) and needs treatment (must have at least 1 lymph node or extranodal lymphoid malignancy measuring = 3 cm in its longest diameter)
- •6. Has radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of = 1 lesion that measures = 3 cm in the longest diameter) as assessed by computed tomography or magnetic resonance imaging
- •7. Has Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- •8. Has adequate hematologic function as defined by:
- •a. Absolute neutrophil count > x1E+09
- •b. Hemoglobin = 8 g/dL
- •c. Platelet count > 75 ×1E+09
- •9. Has adequate renal function as defined by creatinine clearance = 30 mL/min
- •10. Has adequate hepatic function as defined by:
- •a. AST and ALT < 1.5 × upper limit of normal (ULN)
- •b. Total bilirubin < 1.5 × ULN
- •11. Female patients must fulfil the following criteria:
- •a. Be of non-childbearing potential, defined as follows:
- •i. Postmenopausal (ie, = 1 year without any menses) prior to Screening, or
- •ii. Documented surgically sterile (= 1 month prior to Screening)
- •b. If of childbearing potential:
- •i. Agree not to try to become pregnant during the study and for 90 days after the last dose
- •ii. Have a negative pregnancy test at Screening, and
- •iii. If heterosexually active, agree to consistently use 2 different forms of highly effective birth control (at least 1 of which must be a barrier method) starting at Screening and continuing throughout the study until after 90 days after the last dose
- •c. Use highly effective forms of birth control (women of childbearing potential only), which include the following:
- •i. Consistent and correct use of established oral contraception
- •ii. Established intrauterine device or intrauterine system
- •iii. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
- •12. Female patients must agree not to breastfeed starting from the time of Screening, throughout the study, and until after 90 days following the last dose
- •13. Male patients and their female spouse/partners who are of childbearing potential must use highly effective contraception methods consisting of 2 forms of birth control (at least 1 of which must be a barrier method) from the time of Screening, throughout the study, and until after 90 days following the last dose
- •14. Male patients must agree not to donate sperm starting from the time of Screening, throughout the study, and until after 90 days following the last dose
- •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 95
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 44
排除标准
- •Patients meeting any of the following criteria will be excluded from the study:
- •1. Has histologically confirmed diagnosis of Grade 3b follicular lymphoma, or transformation to diffuse large B cell lymphoma. In patients with clinical suspicion of transformed disease, a fresh biopsy is recommended.
- •2. Has a history of central nervous system lymphoma (either primary or secondary).
- •3. Has had prior treatment with abexinostat.
- •4. Has had allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before enrollment.
- •5. Has active graft-versus-host disease.
- •6. Has used prohibited medication (Section 5.7 and Section 5.8) within 7 days or
- •5 half-lives, whichever is shorter, prior to first dose of study drug.
- •7. Has evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation: HBV DNA and HCV RNA must be undetectable. Patients cannot be positive for hepatitis B surface antigen (HBsAg) or anti hepatitis B core antibody. Patients who have positive antibodies against HBsAg as the only evidence of prior exposure may participate in the study provided that there is both:
- •a. no known history of HBV infection, and
- •b. verified receipt of hepatitis B vaccine
- •8. Is taking corticosteroids during the last 1 week prior to Cycle 1 Day 1, unless administered at a dose equivalent to < 20 mg/day prednisone (over this 1 week).
- •9. Has not recovered from a major surgical intervention.
- •10. Is a female who is currently pregnant, breastfeeding, or planning to become pregnant or to breastfeed within 90 days of the last dose of study drug.
- •11. Has any of the following types of cardiac impairment at the time of enrollment:
- •a. New York Heart Association Class III or IV heart disease
- •b. Uncontrolled angina, congestive heart failure, or myocardial infarction within 6 months prior to enrollment
- •c. QTc interval prolongation based on Fridericia’s formula (> 450 ms in males, > 470 ms in females)
- •12. Has received any investigational medication within 30 days or 5 half-lives prior to Day 1, whichever is longer.
- •13. Has prior history of malignancies, other than follicular lymphoma, unless the patient has been free of the disease for = 3 years. Exceptions include localized prostate cancer that is being managed with active surveillance or a history of previously treated:
- •a. Localized non-melanoma skin cancer
- •b. Carcinoma in situ of the cervix
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