EUCTR2018-002896-17-AT进行中（未招募）1 期
A Multicenter, Open-Label, Single-Arm, Phase 2 Study of Zandelisib (ME-401) in Subjects with Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Systemic Therapies - The TIDAL Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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. Age = 18 years (or age of majority)
- •2. Histologically confirmed diagnosis of FL as defined in the WHO classification scheme, limited to Grade 1, 2, or 3a
- •3. Histologically confirmed diagnosis as defined in the World Health
- •Organization (WHO) classification (Swerdlow 2016) of:
- •a. Follicular lymphoma (FL) limited to Grade 1, 2, or 3a; or
- •b. Marginal zone lymphoma (MZL), including nodal, extranodal, and
- •splenic MZL (histopathological report confirming diagnosis must be
- •available during screening procedures).
- •4. Subjects with relapsed or refractory FL or MZL who received =2 prior therapy regimens. A previous regimen is defined as one of the following: at least two months of single-agent therapy or at least two consecutive cycles of polychemotherapy, autologous transplant, or radioimmunotherapy. Prior therapy must include an anti-CD20 monoclonal antibody (mAb) and an alkylating agent(s). Relapsed or refractory disease defined as:
- •a. Relapsed disease: disease progression after a response (CR or PR) lasting =6 months
- •b. Refractory disease: no response to therapy (no CR or PR) or response lasting < 6 months
- •5. At least one bi-dimensionally measurable nodal lesion >1.5 cm orextranodal lesions >1 cm in its longest diameter by computed tomography (CT) scan as defined by the Modified Lugano
- •Classification(Appendix 5).
- •a. Previously irradiated lesions can be selected as target lesions only in cases of unequivocal evidence of progression.
- •b. For subjects with splenic MZL only: diffuse spleen involvement with splenomegaly, which is defined as the splenic vertical length greater than 13 cm.
- •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 (Oken 1982; Appendix 6).
- •7. Adequate hematologic parameters at screening unless abnormal values are due to lymphoma per Investigator assessment:
- •a. Absolute neutrophil count (ANC) =1.0 × 109/L (= 1,000/mm3)
- •b. Platelet count =75.0 × 109/L (= 75,000/mm3)
- •8. Adequate renal and hepatic function per local laboratory reference range at screening as follows:
- •a. Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamicpyruvate transaminase (SGPT) =3.0 × upper limit of normal(ULN)
- •b. Total bilirubin =2.0 × ULN or =3 × ULN for subjects with Gilbert's syndrome
- •c. Serum creatinine =1.5 × ULN or estimated glomerular filtration rate (eGFR) >50 mL/min using the Cockcroft-Gault equation (Appendix 2)
- •9. QT-interval corrected according to Fridericia's formula (QTcF) =450 milliseconds (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.
- •10. Left ventricular ejection fraction (LVEF) = 45% as measured by echocardiogram or multigated acquisition scan (MUGA). If LVEF <45% by ECHO, a repeat measurement can be conducted within the screening period.
- •11. Subjects must have completed any prior systemic anti-cancer treatment within =4 weeks of Cycle 1 Day 1 (or =5 times the half-life [t½], whichever is longer); =8 weeks for antibody agents; =2 weeks for radiation therapy; and =3 months for high dose therapy with stem cell transplantation or CAR T cell therapy or radioimmunotherapy.
- •12. All adverse events and laboratory toxicities related to prior therapy must resolve to Grade =1 prior to the start of the study therapy (unless otherwise specified in eligibility criteria).
排除标准
- •1. Histologically confirmed FL Grade 3b, or transformed disease (assessed by the Investigator):
- •a. For patients with clinical (e.g., marked B-symptoms), laboratory (e.g., high lactate dehydrogenase [LDH]) or radiographic (e.g., high standardized uptake value by positron emission tomography [PET]) signs of rapid disease progression, a fresh tumor biopsy prior to enrollment is required to rule out transformed disease
- •2. Known lymphomatous involvement of the central nervous system.
- •3. Major surgical procedure within 4 weeks prior to study Day 1 (minor surgical procedures, [e.g., lymph node biopsy] performed within 1 day or with an overnight stay are allowed).
- •4. Prior therapy with PI3K inhibitors.
- •5. Any uncontrolled clinically significant illness including, but not limited to, active infections requiring systemic antimicrobial therapy, hypertension, angina, arrhythmias, pulmonary disease, or autoimmune dysfunction
- •6. Subjects who have tested positive for hepatitis B surface antigen and/or hepatitis B core antibody plus have a positive hepatitis B PCR assay; subjects with a negative PCR assay are permitted with appropriate anti-viral prophylaxis
- •7. Positive HCV Ab; subjects with positive hepatitis C antibody are eligible if they are negative for HCV by PCR
- •8. Known history of, or active human immunodeficiency virus (HIV) infection.
- •9. Ongoing or history of drug-induced pneumonitis
- •10. 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 enrollment.
- •11. History of clinically significant cardiovascular abnormalities such as congestive heart failure (New York Heart Association classification = II [NYHA 1994]), myocardial infarction within 6 months of study entry.
- •12. History of clinically significant gastrointestinal (GI) conditions, particularly:
- •a. Known GI condition that would interfere with swallowing or the oral absorption or tolerance of study drug
- •b. Pre-existing malabsorption syndrome or other clinical situation that would affect oral absorption
- •13. Females who are pregnant; females who plan to breastfeed during study treatment through 90 days after ending treatment.
- •14. Psychiatric illness/social situations that would interfere with study compliance.
- •15. Hypersensitivity or other clinically significant reaction to the study drug or its inactive ingredients.
- •16. Any other condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject.
研究者
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