NL-OMON51210已完成3 期
A Phase 3, Randomized, Open-Label, Controlled, Multicenter Study of Zandelisib (ME-401) in Combination with Rituximab Versus Standard Immunochemotherapy in Patients with Relapsed Indolent Non-Hodgkin*s Lymphoma (iNHL) - The COASTAL Study - The COASTAL Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Male or female subjects >=18 years of age, >=19 years in Korea, or >=20 years
- •for subjects in Japan and Taiwan, at time of signing informed consent
- •2. Histologically confirmed diagnosis of CD20 positive iNHL with histological
- •subtype limited to:
- •a. FL Gr 1, Gr 2, or Gr 3a
- •b. MZL (splenic, nodal, or extra-nodal)
- •[Histopathological report confirming diagnosis must be available during
- •screening procedures]
- •3. Subjects with relapsed or refractory disease who received >=1 prior lines of
- •therapy that must have included an anti-CD20 antibody in combination with
- •cytotoxic chemotherapy or L, with or without subsequent maintenance therapy. [A
- •line of therapy is defined as following: a minimum of 2 consecutive cycles of
- •immunochemotherapy or R-L, at least 4 doses of anti-CD20 mAb (R) single agent
- •therapy a minimum of 2 consecutive cycles of therapy with an investigational
- •agent. Maintenance therapy given after an induction treatment (e.g., R
- •maintenance) is considered as the same line of therapy]. [Please seeExclusion
- •Criteria #2 for further clarification]. Relapsed or refractory disease defined
- •Relapsed disease: disease progression after a response (complete response
- •[CR] or partial response [PR]) lasting >=6 months
- •Refractory disease: no response to therapy (no CR or PR) or response lasting
- •4. Subjects must have at least one bi-dimensionally measurable nodal lesion
- •with the longest diameter > 1.5 cm and/or an extranodal lesion >1.0 cm in the
- •longest diameter (that has not been previously irradiated) according to the
- •Lugano Classification
- •5. Adequate hematologic parameters at screening unless abnormal values are due
- •to disease per Investigator assessment:
- •Absolute neutrophil count (ANC) >=1.0 × 109/L (>=1,000/mm3)
- •Platelet count >=75.0 × 109/L (>=75,000/mm3)
- •Hemoglobin >=9 g/dL
- •6. Adequate renal and hepatic function per local laboratory reference range at
- •screening as follows:
- •Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <=1.5 × upper
- •limit of normal (ULN)
- •Total bilirubin <=2.0 × ULN or <=3 × ULN for subjects with Gilbert-Meulengracht
- •Estimated glomerular filtration rate (eGFR) >50 mL/min using the
- •Cockcroft-Gault equation (Appendix 2)
- •7. QT-interval corrected according to Fridericia*s formula (QTcF) <=450 msec;
- •subjects with QTc >450 msec but <480 msec may be enrolled provided the
- •QTc prolongation is due to a right bundle branch block (RBBB), left bundle
- •branch block (LBBB), or pacemaker and is confirmed stable by a cardiologist.
- •8. Left ventricular ejection fraction (LVEF) >=45% as measured by echocardiogram
- •(ECHO) or multi-gated acquisition scan. [If LVEF <45% by ECHO, a repeat
- •measurement can be conducted within the screening period.]
- •9. Subjects must have completed any prior systemic anti-cancer treatment >=4
- •weeks (or >=5 times the half-life [t*] of used therapeutics [including
- •investigational therapy], whichever is longer) or radiation therapy >=2 weeks
- •before study D1, and >=3 months before study D1 for high dose therapy with stem
- •cell transplantation, radioimmunotherapy, and CAR T-cell therapy.
- •10. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •11. Life expectancy of at least 3 months
- 另有 1 项未显示
排除标准
- •1. Histologically confirmed diagnosis of FL Gr 3b or transformed disease
- •For subjects with clinical signs of rapid disease progression (e.g., marked
- •B-symptoms), and laboratory or radiographic indication (e.g., high lactate
- •dehydrogenase level or standardized uptake value by PET), a fresh biopsy is
- •recommended to rule out transformed disease
- •2. Subjects who received both R/O-B and R/O-CHOP (or other
- •anthracycline-containing regimen) as previous lines of therapy, and those who
- •received only single agent anti-CD20 mAb therapy as prior line of treatment
- •3. Prior therapy with PI3K inhibitors
- •4. Ongoing or history of drug-induced pneumonitis
- •5. Known lymphomatous involvement of the central nervous system
- •6. Seropositive for or active viral infection with hepatitis B virus:
- •HBsAg positive
- •HBsAg negative, anti-HBs positive and/or anti-HBc positive and detectable
- •viral DNA by PCR
- •[Note: Subjects who are HBsAg negative and viral DNA PCR negative are eligible.
- •These subjects should receive prophylactic therapy for hepatitis as per
- •institutional standards.]
- •7. Known seropositive for, or active infection with hepatitis C virus.
- •Subjects with positive hepatitis C virus (HCV) antibodies are eligible with
- •negative PCR test for HCV
- •8. Known seropositive for, or active and uncontrolled infection with human
- •immunodeficiency virus (HIV), or with acquired immunodeficiency syndrome
- •(AIDS), or currently taking medications for HIV that are contraindicated for
- •concomitant use in this study
- •9. Known seropositive for, or active infection with human T-cell leukemia virus
- •10. Any uncontrolled clinically significant illness including, but not limited
- •to, active infections requiring systemic antimicrobial therapy, hypertension,
- •angina, arrhythmias or other uncontrolled cardiovascular condition, pulmonary
- •disease, autoimmune dysfunction and urinary infection or flow obstruction.
- •11. Hypersensitivity or other clinically significant reaction to the study drug
- •or its inactive ingredients or other therapy used in the study
- •12. Major surgical procedure within 4 weeks prior to study D1 (minor surgical
- •procedures, e.g., lymph node biopsy, performed within 1 day or with an
- •overnight stay are allowed)
- •13. Previous or concurrent cancer that is distinct in primary site or histology
- •from indolent B cell NHL within 3 years before start of study treatment except
- •for curatively treated cervical cancer in situ, non-melanoma skin cancer, and
- •superficial bladder tumors (Ta [non-invasive tumor], Tis [carcinoma in situ],
- •and T1 [tumor invades lamina propria]), and asymptomatic localized prostate
- •cancer with no requirement for systemic therapy or requiring only hormonal
- •therapy and with normal prostate-specific antigen values within >=12 months
- •prior to randomization
- •14. History of clinically significant cardiovascular abnormalities such as
- •congestive heart failure (New York Heart Association (NYHA) classification >= II
- •[NYHA 1994]), myocardial infarction within 6 months of study entry.
- •15. History of clinically significant gastrointestinal (GI) conditions,
- •particularly:
- •Known GI condition that would interfere with swallowing or the oral
- •absorption or tolerance of study drug
- 另有 2 项未显示
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