EUCTR2020-004954-31-NL进行中（未招募）1 期
Single-Arm, Phase 2 Study of Valemetostat Tosylate Monotherapy in Subjects with Relapsed/Refractory Peripheral T-Cell Lymphoma - Valemetostat tosylate (DS-3201b), an enhancer of zeste homolog (EZH) 1/2 dual inhibitor, for R/R PTC
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 176
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. Sign and date the ICF, prior to the start of any study-specific qualification procedures.
- •2. Subjects =18 years of age or the minimum legal adult age (whichever is greater) at the time the ICF is signed.
- •3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
- •4. Cohort 1 (R/R PTCL): Should be pathologically confirmed by the local pathologist/investigators; local histological diagnosis will be used for eligibility determination, but histology will be centrally reviewed following study entry. Subjects with the following subtypes of PTCL are eligible, according to 2016 World Health Organization classification prior to the initiation of study drug. Any T-cell lymphoid malignancies not listed below are excluded. Below is the complete list of eligible subtypes:
- •- Enteropathy-associated T-cell lymphoma
- •- Monomorphic epitheliotropic intestinal T-cell lymphoma
- •- Hepatosplenic T-cell lymphoma
- •- Primary cutaneous ?d T-cell lymphoma
- •- Primary cutaneous CD8+ aggressive epidermotropic cytotoxic T-cell lymphoma
- •- PTCL, not otherwise specified
- •- Angioimmunoblastic T-cell lymphoma
- •- Follicular T-cell lymphoma
- •- Nodal PTCL with TFH phenotype
- •- Anaplastic large cell lymphoma, ALK positive
- •- Anaplastic large cell lymphoma, ALK negative
- •5. Cohort 2 (R/R ATL): (acute, lymphoma, or unfavorable chronic type) with positive anti-human T-cell leukemia
- •virus type 1 (anti-HTLV-1) antibody. R/R ATL should be pathologically or hematocytologically confirmed by the local pathologist/investigators. The positivity of anti-HTLV-1 antibody will be locally confirmed.
- •6. Must have at least 1 of the following lesions which are measurable in 2 perpendicular dimensions on CT (or MRI) based on local radiological read:
- •- Longest diameter (LDi) =2.0 cm for a nodal lesion
- •- LDi >1.0 cm for an extranodal lesion
- •For Cohort 2 (ATL), subjects who had disease only in peripheral blood or/and skin lesions are eligible, as defined below.
- •o An abnormal lymphocyte count (actual number) is =1.0 × 10^9 /L and the abnormal lymphocyte-to-leucocyte ratio is =5%.
- •o Skin lesion(s) measured by modified severity weighted assessment tool (mSWAT) score.
- •7. Documented failure to achieve CR (or uncertified CR [CRu] for ATL) from prior systemic lymphoma therapy, or relapsed disease (after CR or CRu for ATL), or progressive disease (after PR or stable disease).
- •8. Must have at least 1 prior line of systemic therapy for PTCL or ATL.
- •- Subjects must also be considered as HCT-ineligible during Screening due to disease status (active disease), comorbidities, or other factors; in case of other factors, the eligibility should be discussed with the study medical monitor, and the reason must be clearly documented.
- •- In Cohort 1, subjects with ALCL must have prior brentuximab vedotin treatment.
- •Please refer to the protocol for the full list of inclusion criteria.
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 106
排除标准
- •1. Diagnosis of mycosis fungoides, Sézary syndrome, and primary cutaneous ALCL and systemic dissemination of primary cutaneous ALCL
- •2. Diagnosis of precursor T-cell lymphoblastic leukemia and lymphoma (T-cell acute lymphoblastic leukemia and T-cell lymphoblastic leukemia), T-cell prolymphocytic leukemia, or T-cell large granular lymphocytic leukemia
- •3. Prior malignancy active within the previous 2 years except for locally curable cancer that is currently considered as cured, such as cutaneous basal or squamous cell carcinoma, superficial bladder cancer, or cervical carcinoma in situ, or an incidental histological finding of prostate cancer
- •4. Presence of active central nervous system (CNS) involvement of lymphoma
- •5. History of autologous HCT within 60 days prior to first dose of study drug
- •6. History of allogeneic HCT within 90 days prior to the first dose of study drug
- •7. Clinically significant graft-versus-host disease (GVHD) or GVHD requiring initiation of systemic treatment or systemic treatment escalation
- •8. Inadequate washout period from prior lymphoma-directed therapy before enrollment, defined as follows:
- •- Prior systemic therapy (eg, chemotherapy, immunomodulatory therapy, or monoclonal antibody therapy) within 3 weeks prior to the first dose of study drug
- •- Had curative radiation therapy or major surgery within 4 weeks or palliative radiation therapy within 2 weeks prior to the first dose of study drug
- •9. Uncontrolled or significant cardiovascular disease, including the following:
- •- Evidence of prolongation of QT/QTc (eg, repeated episodes of QT corrected for heart rate using Fridericia’s method [QTcF] >450 ms) (average of triplicate determinations)
- •- Diagnosed or suspected long QT syndrome, or known family history of long QT syndrome
- •- History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes
- •- Uncontrolled arrhythmia (subjects with asymptomatic, controllable atrial fibrillation may be enrolled), or asymptomatic persistent ventricular tachycardia
- •- Subject has clinically relevant bradycardia of <50 bpm unless the subject has a pacemaker
- •- History of second- or third-degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers, and have no history of fainting or clinically relevant arrhythmia with pacemakers, within 6 months prior to Screening
- •- Myocardial infarction within 6 months prior to Screening
- •- Angioplasty or stent graft implantation within 6 months prior to Screening
- •- Uncontrolled angina pectoris within 6 months prior to Screening
- •- New York Heart Association (NYHA) Class 3 or 4 congestive heart failure
- •- Coronary/peripheral artery bypass graft within 6 months prior to Screening
- •- Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg)
- •- Complete left or right bundle branch block
- •10. History of treatment with other EZH inhibitors
- •11. Current use of moderate or strong cytochrome P450 (CYP)3A inducers (Table 10.4)
- •12. Systemic treatment with corticosteroids (>10 mg daily prednisone equivalents). Note: Short-course systemic corticosteroids (eg, prevention/treatment for transfusion reaction) or use for a non-cancer indication (eg, adrenal replacement) is permissible.
- •Please refer to the protocol for the full list of exclusion criteria.
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