EUCTR2019-001123-13-IT进行中（未招募）1 期
A Multi-Center, Phase 2, Open-label, Parallel Cohort Study of Efficacy and Safety of Duvelisib in Patients with Relapsed or Refractory Peripheral T-cellLymphoma (PTCL). -
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
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. >= 18 years of age
- •2. Pathologically-confirmed PTCL, as defined by the World Health Organization. Slides must be submitted for central pathology review. Results of central pathology review are not required prior to initiation of treatment.
- •3. Received at least 2 cycles of a standard prior regimen for newly diagnosed advanced PTCL and one of the following:
- •(a) failed to achieve at least a partial response after 2 or more cycles of standard therapy;
- •(b) failed to achieve a complete response after completion of standard therapy; and/or
- •(c) persistent or progressive disease after an initial response
- •4. For patients with CD30+ anaplastic large cell lymphoma (ALCL), failed or are ineligible or intolerant to brentuximab vedotin
- •5. Measurable disease as defined by Lugano for PTCL, i.e., at least 1 measurable disease lesion > 1.5 cm in at least one dimension by conventional techniques (18FDG-PET-CT, CT with contrast, MRI)
- •6. Must have the following laboratory parameters:
- •Hemoglobin >= 8.0 g/dL with or without transfusion support
- •Platelet count >= 25 × 109/L
- •Serum creatinine < = 2.0 × the upper limit of normal (ULN)
- •Total bilirubin <= 1.5 × ULN (in patients with Gilbert's Syndrome a bilirubin > 1.5 × ULN may be allowed)
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3.0 × ULN
- •Expansion Phase Only: CD4 lymphocyte count >= 50/mm3; (0.05 x 109/L)
- •7. Eastern Cooperative Oncology Group (ECOG) performance status <= 2
- •8. Recovery to <= Grade 1 or baseline for any toxicities due to prior treatments, with the exception of peripheral neuropathy (recovery to <= Grade 2) or alopecia
- •9. Washout of at least 14 days or 5 half-lives, whichever is longer, from PTCL-directed therapy. If previously treated with lenalidomide, must have completed treatment 4 weeks prior to C1D1
- •10. For women of childbearing potential (WCBP): negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test within 1 week before first treatment (WCBP defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally post-menopausal for at least 12 consecutive months for women > 55 years of age)
- •11. Male and female patients of reproductive potential (i.e., not surgically sterile or female patients who are not postmenopausal) must be willing to use a highly effective method of contraception for the duration of study treatment and for at least 3 months after the last dose of duvelisib
- •12. Signed and dated institutional review board (IRB)/independent ethics committee (IEC)/central ethics committee (CEC)-approved informed consent form before any 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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •1. Primary leukemic PTCL subtypes (i.e., T-cell prolymphocytic leukemia,T-cell large granular lymphocytic leukemia, Adult T-cell leukemia/lymphoma, Aggressive NK-cell leukemia or transformed mycosis fungoides)
- •2. Received prior allogeneic transplant
- •3. Received prior treatment with a PI3K inhibitor
- •4. Major surgery within 4 weeks prior to Screening
- •5. Known central nervous system involvement by PTCL
- •6. Infection with hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or Human T-lymphotropic virus type 1 (HTLV-1). (Patients with a positive hepatitis B surface antigen [HBsAg] or hepatitis C antibody [HCVAb] will be excluded. Patients with a positive hepatitis B core antibody [HBcAb] must have negative hepatitis B virus [HBV] deoxyribonucleic acid (DNA) to be eligible, must receive prophylaxis with entecavir [or equivalent] concomitant with duvelisib treatment, and must be periodically monitored for HBV reactivation by institutional guidelines. Investigators who strongly believe that 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.)
- •7. Active cytomegalovirus (CMV) infection (patients with detectable viralload)
- •8. History of tuberculosis treatment within 2 years prior to C1D1
- •9. History of chronic liver disease, veno-occlusive disease, or alcohol abuse
- •10. Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids > 20 mg of prednisone (or equivalent)once daily (QD)
- •11. Ongoing treatment for systemic bacterial, fungal, or viral infection at Screening. NOTE: Patients on antimicrobial, antifungal, or antiviral prophylaxis are not specifically excluded if all other inclusion/exclusion criteria are met
- •12. Administration of a live vaccine within 6 weeks of C1D1
- •13. Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 3A (CYP3A)
- •14. Unable to receive prophylactic treatment for pneumocystis at Screening
- •15. Baseline left ventricular ejection fraction (LVEF) < 50% (or below institution's normal limit)
- •16. Baseline QT interval corrected with Fridericia's method (QTcF) > 480msNOTE: criterion does not apply to patients with a right or left bundle branch block
- •17. Prior surgery or condition with gastrointestinal dysfunction that may significantly affect drug absorption (e.g., gastric bypass surgery, gastrectomy, clinically significant medical condition of malabsorption, inflammatory bowel disease, chronic conditions which manifest with diarrhea, refractory nausea, vomiting)
- •18. If female, pregnant or breastfeeding
- •19. Concurrent active malignancy other than nonmelanoma skin cancer, carcinoma in situ of the cervix. NOTE: Patients with previous malignancies are eligible if disease-free for> 2 years.
- •20. History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or a pacemaker within the last 6 months prior to Screening
- •21. Unstable or severe uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition, uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the Investigator's judgment, increase the risk to the patient associated with his or her participation in the study.
- •22. Known hypersensitivity to duvelisib and/or its excipients
研究者
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