EUCTR2015-004729-15-IT进行中（未招募）1 期
A Phase 2, Randomized Study of Duvelisib Administered in Combination with Rituximab vs R-CHOP in Subjects with Relapsed/Refractory Follicular Lymphoma - ¿Subjects with previously treated Follicular Lymphoma who will be re-treated with a combination of t
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 230
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.Diagnosis of FL: Grade 1, 2, or 3a
- •2.Subjects must have received rituximab, either as single agent or as part of any combination regimen, and also meet one of the following requirements (see Appendix 7 for more details):
- •a. Progressed within 24 months of initiating alkylator-based chemotherapy in the first line and received no additional anticancer therapy
- •b. Progressed within 24 months of initiating alkylator-based chemotherapy in the first line and subsequently progressed within 24 months of receiving any second-line treatment and received no additional anticancer therapy
- •c. Progressed within 24 months of initiating alkylator-based chemotherapy in the second line and received no additional anticancer therapy
- •3.Previously received rituximab
- •4.Appropriate to receive R-CHOP
- •5.At least 1 measurable disease lesion > 1.5 cm in at least one dimension by computed tomography (CT), CT-PET, or magnetic resonance imaging (MRI)
- •6.Eastern Cooperative Oncology Group (ECOG) performance status =2 (corresponds to Karnofsky Performance Status [(KPS) =60%])
- •7.For women of childbearing potential (WCBP): negative serum ß human chorionic gonadotropin (ßhCG) 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)
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1.Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3B FL
- •2.Received = 3 previous anticancer regimens prior to enrollment
- •3.Received prior R-CHOP therapy
- •4.Previous receipt of any anthracycline
- •5.Contraindication to any of the individual components of CHOP (cyclophosphamide, vincristine, doxorubicin and prednisone) Severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine protein, or known hypersensitivity to any of the study drugs
- •6.Received prior allogeneic transplant
- •7.Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor
- •8.History of tuberculosis treatment within the two years prior to randomization
- •9.History of chronic liver disease, veno-occlusive disease, alcohol abuse
- •10.Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids >20 mg of prednisone (or equivalent) QD
- •11.Ongoing treatment for systemic bacterial, fungal, or viral infection at screening antifungal, or
- •12.Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 3A (CYP3A)
- •13.Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening
- •14.Concurrent active malignancy other than nonmelanoma skin cancer, carcinoma in situ of the cervix.
- •15.History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or a pacemaker within the last 6 months prior to screening
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