EUCTR2020-005225-81-BE进行中（未招募）1 期
A PHASE II OPEN-LABEL STUDY EVALUATING VALEMETOSTAT TOSYLATE AS A SINGLE AGENT IN PATIENTS WITH RELAPSE/REFRACTORY B-CELL LYMPHOMA - VALYM
YSARC0 个研究点目标入组 141 人开始时间: 2021年4月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 141
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 Participants with confirmed histological diagnosis of aggressive Bcell lymphoma (diffuse large B-cell lymphoma-not otherwise specified, primary mediastinal B-cell lymphoma, high grade B-cell lymphoma-not otherwise specified and high grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rerrangement, transformed indolent lymphoma and grade
- •3b follicular lymphoma), FL (grade 1, 2, 3a), MCL, MZL or other indolent lymphoma (Waldenström macroglobulinemia, lymphoplasmacytic lymphoma), or HL according to the World Health Organization (WHO)
- •2016 classification of hematopoietic and lymphoid tissue
- •2 Participant who had progressive disease (PD) or did not have a
- •response (CR or PR) in previous systemic therapy, or relapsed or
- •progressed after previous systemic therapy
- •3 Participant who has measurable disease by the Lugano criteria (ie
- •longest diameter of a nodal site > 1.5cm and/or longest diameter of an extranodal site > 1.0 cm)
- •4 Participant who had previous standard therapy with at least:
- •(note: patients having received prior CAR-T therapy can be enrolled):
- •a For aggressive B-cell lymphoma: 2 prior lines of therapy (in
- •transformed indolent lymphoma patient must have received at least one line of treatment containing an anthracycline-based regimen before or after transformation) containing an anti-CD20 antibody and an anthracycline (unless anthracycline-based therapy is contraindicated) and patient deemed ineligible for high-dose therapy and ASCT based on physician's assessment or age = 65 years or with a hematopoietic cell transplantation-specific comorbidity index (HCT-CI) score =3. In the best interest of the patient, the treating physician must ensure CAR-T have been discussed among the treament options before considering enrollment in this study
- •b For FL, MZL and other indolent NHL: 2 prior lines of systemic therapy with at least one anti-CD20 monoclonal antibody. Local involved field radiotherapy for limited stage disease is not considered as a previous line. Subjects with prior ASCT or CAR-T cells may be included. In the best interest of the patient, the treating physician must ensure CAR-T have been discussed among the treament options before considering enrollment in this study. Note: for Splenic Marginal Zone Lymphoma (SMZL), splenectomy is considered as one line; for Extranodal Marginal Zone Lymphoma (ENMZL), Helicobacter pylori eradication is not considered as a previous line, indolent (ie FL or MZL) relapse after aggressive B-cell lymphoma can be enrolled and prior treatment lines for the aggressive lymphoma are taken into account for inclusion criteria
- •c For MCL: 2 prior lines including at least one immunochemotherapy
- •and one BTK inhibitor
- •d For HL: 3 prior lines including at least one line with anthracyclinebased chemotherapy (unless anthracycline-based therapy is contraindicated), one line containing brentuximab-vedotin and one line containing an anti-PD1 or anti-PDL1 antibody and patient deemed ineligible for high-dose therapy and ASCT based on physician's assessment or age = 65 years or with a HCT-CI score =3
- •5 ECOG performance status of 0 to 2
- •6 Adequate renal function defined as calculated creatinine clearance = 40 mL/min per the Cockcroft and Gault formula
- •7 Adequate bone marrow function:
- •- ANC > 1000/mm3 (= 1 × 109/L) without G-CSF for at least 7 days
- •- Platelets = 75,000/mm3 (= 75 × 109/L /L) [...]
- •- Hemoglobin > 8.0 g/dL [...]
- •8. Adequate liver function:
- •- Total bilirubin < 1.5 × the ULN except for unconjugated
排除标准
- •1.Participant with prior exposure to EZH2 inhibitor
- •2.Participant with active lymphomatous involvement of the central nervous system (CNS) at screening
- •3.Any prior treatment-related (ie, chemotherapy, immunotherapy, radiotherapy), clinically significant toxicities that have not resolved to = Grade 1 per CTCAE version 5.0, or prior treatment-related toxicities that are clinically unstable and clinically significant at time of enrollment.
- •4.Major surgery within 4 weeks before the first dose of study drug.
- •5.Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (eg, nausea, diarrhea, or vomiting) that might impair the bioavailability of the drug
- •6. Subjects currently taking medications that are known moderate or strong CYP3A inducers (refer to Appendix 7 for a list of example drugs)
- •oIf currently used, these medications need to be discontinued at least 14 days prior to study drug administration; replacement by alternative medications that are not moderate or strong CYP3A inducers can be considered according to medical need
- •7.Vaccinated with live, attenuated vaccines within 6 months of enrollment (except COVID vaccine)
- •8.Use of any standard or experimental anti-cancer drug therapy within 4 weeks or a minimum of 3 half lives of the drug, whatever the shortest prior to first administration of study drug,
- •9.History of CAR T-cells therapy within 30 days prior to the first dose of study drug
- •10.History of autologous or allogeneic HCT within 90 days prior to the first dose of study drug
- •11.Patients taking corticosteroids within 2 weeks prior to first administration of study drug, unless administered at a cumulated dose equivalent of prednisone to = 10mg/ day (within these 2 weeks).
- •12.Participant with significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug; or cardiac ventricular arrhythmia
- •13.Subjects with malignancies other than B cell lymphomas except subjects who have been disease-free for 2 years (subjects with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible).
- •14.Positive serology of human immunodeficiency virus (HIV)
- •15.Participant with prolongation of corrected QT interval using Fridericia's formula (QTcF) to > 470 milliseconds (msec) (obtained on average of 3 ECGs)
- •16.Participant with venous thrombosis or pulmonary embolism not treated
- •17.Participant with complications of hepatic cirrhosis, interstitial pneumonia, or pulmonary fibrosis
- •18.Participant with active infection requiring systemic therapy
- •19.Woman who are pregnant (positive serum pregnancy test at screening) or breastfeeding
- •20. Participant who were deemed as inappropriate to participate in the study by the investigator or sub-investigator
研究者
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