EUCTR2019-001381-14-CZ进行中（未招募）1 期
A Phase 2, Randomized, Open-label, 2-Arm Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects with Indolent Non-Hodgkin Lymphoma (iNHL) - A Phase 2 Study of Intermittent Dosing Schedules of Duvelisib in Indolent Non-Hodgkin Lymphoma(iNHL)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 102
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
- •1. Male or female subjects = 18 years of age
- •2. Histologically confirmed diagnosis of iNHL. Histologic subtypes include FL Grades 1 to
- •3a, marginal zone lymphoma (splenic, nodal, or extranodal), or SLL.
- •3. Must have received at least 1 prior systemic regimen for iNHL
- •4. Must have documented radiologic evidence of disease progression, at least 1 Bidimensionally measurable lesion = 1.5 cm (which has not been previously irradiated),
- •according to 2007 revised IWG criteria (Cheson 2007) and be a candidate for a subsequent line of therapy
- •5. Must have adequate organ function defined by the following laboratory parameters:
- •a. Absolute neutrophil count (ANC) = 1.0 × 109/L
- •b. Platelet count = 75 × 109/L
- •c. Hemoglobin = 8 g/dL
- •d. Estimated creatinine clearance (eCCr) = 60 mL/min, as determined by
- •the Cockcroft-Gault method (Cockcroft 1976)
- •e. Total bilirubin = 1.5 × upper limit of normal (ULN) (exception:
- •subjects with Gilbert's Syndrome may have a bilirubin > 1.5 × ULN)
- •f. Aspartate transaminase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and
- •alanine aminotransferase (ALT)/serum pyruvic transaminase (SGPT) = 3.0 × ULN
- •6. Eastern Cooperative Oncology Group (ECOG) performance status = 2
- •7. Male and female subjects of reproductive potential (i.e., not surgically
- •sterile or female subjects who are not postmenopausal) must be willing to use highly effective methods of contraception (see Section 10.4) for the duration of the study intervention and for
- •3 months after the last dose of duvelisib
- •8. Negative serum human chorionic gonadotropin (hCG) pregnancy test within 7 days
- •before first dose of study intervention if the subject is a woman of childbearing potential
- •(WCBP) (defined in Section 10.4)
- •9. Signed and dated institutional review board (IRB)/independent ethics committee
- •(IEC)-approved informed consent form before any study specific-screening procedures
- •are performed
- •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 51
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 51
排除标准
- •1. Anticancer treatment, major surgery, or use of any investigational drug within 28 days
- •before the start of study intervention; palliative radiation therapy is allowed if > 7 days
- •before planned first dose of study interventions and any toxicity is Grade = 1.
- •2. Clinical or histological evidence of transformation to a more aggressive subtype of Lymphoma or grade 3b FL or Richter’s transformation or CLL
- •3. Received prior allogeneic hematopoietic stem cell transplant (HSCT)
- •4. Previous treatment with a PI3K inhibitor
- •5. Known hypersensitivity to duvelisib and/or its excipients
- •6. History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function
- •7. Prior history of drug-induced colitis or drug-induced pneumonitis
- •8. History of tuberculosis treatment within the 2 years prior to randomization
- •9. Administration of a live or live attenuated vaccine within 6 weeks of randomization
- •10. Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic
- •steroids > 20 mg of prednisone (or equivalent) per day
- •11. Ongoing treatment for systemic bacterial, fungal, or viral infection at screening
- •Note: Subjects on antimicrobial, antifungal, or antiviral prophylaxis are not specifically excluded if all other inclusion/exclusion criteria are met
- •12. Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection (i.e., subjects with
- •detectable viral load)
- •13. Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening
- •14. Infection with hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
- •Subjects with a positive hepatitis B surface antigen [HBsAg] or hepatitis C antibody
- •[HCV Ab] will be excluded
- •Subjects with a positive hepatitis B core antibody (HBcAb) must have negative hepatitis B virus (HBV) deoxyribonucleic acid (DNA) to be eligible and must be periodically monitored for HBV reactivation by institutional guidelines
- •Investigators who strongly believe that a positive HBcAb is false due to passive
- •immunization from previous immunoglobulin infusion therapy should discuss the
- •potential to defer HBV prophylaxis with the Medical Monitor
- •15. Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 3A (CYP3A). No prior use within 2 weeks before the start of study intervention.
- •16. Subjects with clinically significant medical condition of malabsorption, inflammatory
- •bowel disease, chronic conditions which manifest with diarrhea, refractory nausea,
- •vomiting, or any other condition that will interfere significantly with drug absorption
- •17. Central nervous system non-Hodgkin lymphoma (NHL); lumbar puncture not required
- •unless central nervous system involvement is clinically suspected
- •18. Baseline QTcF > 500 ms (average of triplicate readings). NOTE: This criterion does not
- •apply to subjects with a right or left bundle branch block.
- •19. Concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ
- •of the cervix, bladder cancer, or prostate cancer not requiring treatment. Subjects with
- •previous malignancies are eligible if they have been disease-free for 2 years or more.
- •20. History of chronic liver disease, veno-occlusive disease/sinusoidal obstruction syndrome,
- •alcohol abuse, or illicit drug use
- •21. History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia
- •requiring medication or mechanical control within the
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