NCT03349333已完成3 期
A Multi-center, Single Arm, Safety and Efficacy Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation in Subjects With Relapsed or Refractory Peripheral T-cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Objective Response Rate(ORR) by International Working Group Criteria
研究概览
简要总结
This is a single arm, open-label, multi-center study designed to demonstrate the efficacy and safety of pralatrexate when administered concurrently with vitamin B12 and folic acid supplementation to patients with relapsed or refractory peripheral T-cell lymphoma(PTCL).
详细描述
The primary objective of this study is to confirm the objective response rate (ORR) among Chinese subjects with relapsed or refractory PTCL treated with pralatrexate together with concurrent vitamin B12 and folic acid supplementation
Primary endpoint is objective Response Rate by International Working Group Criteria
This study includes 3 phases: Screening, Treatment (pralatrexate) and Follow-up phases.
Screening Phase:
The screening phase will be up to 28 days duration (depending on availability of lab results).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has histologically/cytologically confirmed PTCL, using the World Health Organization (WHO) disease classification:
- •PTCL not otherwise specified (NOS)
- •Angioimmunoblastic T-cell lymphoma
- •Anaplastic large cell lymphoma, ALK+
- •Anaplastic large cell lymphoma, ALK-
- •Extranodal NK/T-cell lymphoma - nasal type
- •Enteropathy-associated T cell lymphoma
- •Hepatosplenic T-cell lymphoma
- •Subcutaneous panniculitis-like T-cell lymphoma
- •Adult T-cell lymphoma/leukemia (human T-cell leukemia virus [HTLV] 1+)
- •Aggressive NK-cell leukemia
- •Transformed mycosis fungoides
- •Subject has to have documented progressive disease (PD) after at least 1 prior systemic treatment.
- •Subject may not have received an experimental drug or biologic as their only prior therapy. Subject must have clear PD after the last treatment received. Subject should have at least 1 biopsy from initial diagnosis or in the relapsed setting to confirm the diagnosis of PTCL. Subject must have recovered from the toxic effects of prior therapy.
- •Subjects with an enlarged lymph node or extranodal mass lesion clearly measurable in two perpendicular directions and greater than 1.5 cm maximum diameter on computed tomography performed within 14 days prior to study enrollment.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤
- •At least 18 years of age.
- •Expected life expectancy ≥ 3 months.
- •Adequate hematological, hepatic, and renal function as defined by:
- •Absolute neutrophil count (ANC) ≥ 1000/uL (or 1*109/L), platelet count ≥ 100,000/uL (or 100*109/L) (at both screening and within 3 days prior to dosing on cycle 1, day 1)
- •Total bilirubin ≤ 1.5 mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 X upper limit of normal (ULN) (AST/ALT < 5 X ULN if documented hepatic involvement with lymphoma)
- •Creatinine ≤ 1.5 mg/dL (or 132.6 µmol/L) or a calculated creatinine clearance ≥ 50 mL/min
- •Women of childbearing potential must have agreed to practice a medically acceptable contraceptive regimen from study treatment initiation until at least 30 days after the last administration of pralatrexate and must have a negative serum pregnancy test within 14 days prior to the first day of study treatment. Subjects who are postmenopausal for at least 1 year (> 12 months since last menses) or are surgically sterilized did not require this test.
- •Men who are not surgically sterile must agree to practice a medically acceptable contraceptive regimen from study treatment initiation until at least 90 days after the last administration of pralatrexate.
- •Subject gives written informed consent (IC).
排除标准
- •Subject has:
- •Precursor T-cell lymphoma or leukemia
- •T-cell prolymphocytic leukemia (T-PLL)
- •T-cell large granular lymphocytic leukemia
- •Mycosis fungoides, other than transformed mycosis fungoides
- •Sézary syndrome
- •Primary cutaneous CD30+ T-cell disorders: Lymphoid papulosis and primary cutaneous anaplastic large cell lymphoma
- •Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix). If there is a history of prior malignancy, the patient must be disease-free for ≥ 5 years.
- •Congestive heart failure Class III/IV according to the New York Heart Association's Heart Failure guidelines.
- •Human immunodeficiency virus (HIV)-positive diagnosis.
- •Has, or history of, brain metastases or central nervous system (CNS) disease.
- •Active uncontrolled infection, underlying medical condition including unstable cardiac disease, or other serious illness that would impair the ability of the subject to receive protocol treatment.
- •Has major surgery within 2 weeks of study entry.
- •Receipt of any conventional chemotherapy or radiation therapy (RT) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study treatment or planned use during the course of the study.
- •Receipt of corticosteroids within 7 days of study treatment, unless subject has been taking a continuous systemic dose of no more than 10 mg/day or equivalent dose of prednisone, or a local or inhaled or intranasal administration at fixed doses for at least 1 month prior to study treatment and tumor shrinkage was not observed.
- •Use of any investigational drugs, biologics, or devices within 4 weeks prior to study treatment or planned use during the course of the study.
- •Receipt of anti-tumor antibody therapy within 100 days prior to study treatment.
- •History of allogeneic hematopoietic stem cell transplantation. Or subjects with a history of autologous hematopoietic stem cell transplantation within 100 days prior to study treatment.
- •Previous exposure to pralatrexate.
- •Subject is pregnant or breast-feeding
研究组 & 干预措施
pralatrexate
Experimental
Vitamin B12 and folic acid will be taken concurrently with pralatrexate
干预措施: pralatrexate (Drug)
pralatrexate
Experimental
Vitamin B12 and folic acid will be taken concurrently with pralatrexate
干预措施: Vitamin B12 and folic acid (Dietary Supplement)
结局指标
主要结局
Objective Response Rate(ORR) by International Working Group Criteria
时间窗: 2 years
ORR defined as the percentage of subjects with CR, CRu or PR as Best Overall Response.Evaluation of response must be performed within 7 days prior to the projected first dose of cycle 2-4 and then within 7 days prior to the projected first dose of every even-numbered subsequent cycle (i.e. prior to cycles 6, 8, etc). Unscheduled radiological response assessments will be performed earlier if clinical progression is suspected.The primary analysis will be conducted once all subjects have completed cycle 5 treatment or discontinued before. Study treatment may continue per investigator judgment for a maximum of 24 months. Response will be assessed on the basis of clinical, radiological, and pathological criteria. Response will be assessed by independent central review and by the treating investigator. Central review assessors will be blinded to the response assessments by the treating investigator. The primary analysis will be based on response assessed by central review.
次要结局
- Duration of Responses(4 years)
- Time to Response (TTR)(2 years)
- Overall Survival (OS)(4 years)
- Steady State Volume of Distribution [Vdss] for R-pralatrexate(Cycle 1 day 1, Cycle 1 week6(Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection))
- Progression-Free Survival (PFS)(2 years)
- Percentage of Participants With Treatment Emergent Adverse Events(4 years)
- Area Under the Curve [AUC] for R-pralatrexate(Cycle 1 day1，Cycle 1 week 6(Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection))
- Area Under the Curve [AUC] for S-pralatrexate(Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）)
- Steady State Volume of Distribution [Vdss] for S-pralatrexate(Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）)
- Steady State Clearance [CLss] for R-pralatrexate(Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）)
- Steady State Clearance [CLss] for S-pralatrexate(Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）)
- Maximum Observed Plasma Concentration [Cmax] for R-pralatrexate(Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）)
- Maximum Observed Plasma Concentration [Cmax] for S-pralatrexate(Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）)
- Terminal Phase Half-life [t1/2Z] for S-pralatrexate(Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）)
- Terminal Phase Half-life [t1/2Z] for R-pralatrexate(Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）)
- Time of Cmax Observation [Tmax] for R-pralatrexate(Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）)
- Time of Cmax Observation [Tmax] for S-pralatrexate(Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）)
研究者
研究点 (1)
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