EUCTR2018-002896-17-DE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 LymphomaAfter Failure of Two or More Prior Systemic Therapies – The TIDAL Study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 188
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. Signed informed consent.
- •2. Age =18 years (or age of majority).
- •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 is 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 or
- •extranodal 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
- •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
- •11. Subjects must have completed any prior systemic anti-cancer
- 另有 7 项未显示
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
- •polymerase chain reaction (PCR) assay; subjects who have previously
- •tested positive with a negative PCR assay are permitted with appropriate
- •anti-viral prophylaxis.
- •7. Positive hepatitis C virus antibody (HCV Ab); subjects with positive
- •HCV Ab are eligible if they are negative for HCV by PCR.
- •8. Known history of, or active human immunodeficiency virus (HIV)
- •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, nonmelanoma
- •skin cancer, 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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