NL-OMON51259已完成2 期
Single-Arm, Phase 2 Study of Valemetostat Tosylate Monotherapy in Subjects with Relapsed/Refractory Peripheral T-Cell Lymphoma - VALENTINE-PTCL01
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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,
- •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 γδ 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)
- •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.
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
- •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
- •- 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
- •- 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
- •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 rep
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