TRIAL OF MOTEXAFIN GADOLINIUM (MGD) IN PATIENTS WITH NON-HODGKIN'S LYMPHOMA

莫替沙芬钆 (MGD) 在非霍奇金淋巴瘤患者中的试验

• 批准号: 7375269
• 负责人: RAJ ADVANI
• 金额: $ 1.51万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7375269
• 关键词: TRIAL; MOTEXAFIN; GADOLINIUM; MGD; PATIENTS

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. To assess the clinical response rate (complete response [CR], unconfirmed complete response [CRu], and partial response [PR]), to Motexafin Gadolinium (MGd) in patients with relapsed or refractory indolent non-Hodgkin's Lymphoma (NHL) Secondary; -To assess the combined clinical benefit rate (CR, CRu, and PR, stable disease [SD]) -To assess progression-free survival -To assess duration of clinical response -To evaluate the safety and tolerability of MGd in this patient population Study Design: A one-arm, open-label, Phase II study based on a Simon 2-Stage design enrolling approximately 15 patients in Stage 1 and 20 patients in Stage 2, for a total of 35 patients. The study will consist of up to six 28-day cycles, or 168 days, with a follow-up period of up to 1 yr for patients showing clinical benefit. Patients who meet the eligibility criteria will be enrolled sequentially and treated daily with 6.0 mg/kg MGd on days 1 through 3 (Treatment A) and days 15 through 17 (Treatment B) of each 28-day cycle. Patients will be evaluated for response between days 21 and 28 of cycles 2, 4, and 6. Patients will be followed until disease progression, disease relapse, or for one year after treatment is completed. Patients with progressive disease (PD) or relapsed disease (RD) at any time will be terminated from the study. Duration: Enrollment will be completed in approximately 1 yr. Individual patients will participate in the study for up to 18 months. Study Population: Adults with refractory or relapsed indolent NHL with Eastern Cooperative Oncology Group (ECOG) performance status scores of 0, 1, or 2. Endpoints: Primary: -Clinical response rate (CR, CRu, PR) to MGd in patients with relapsed or refractory indolent NHL Secondary: -Clinical benefit rate (CR, CRu, PR, SD) -Progression-free survival -Duration of clinical response -Safety and tolerability of MGd in the treatment of indolent NHL Investigational Drug: MGd 6.0 mg/kg/day administered intravenously (IV) once a day (q d) on Treatment A, Days 1 through 3, and Treatment B, days 15 through 17, of each 28-day cycle, over 30 minutes. Visit Schedule: Screening visit within 14 days of first dose. Treatment visits: Once daily on Days 1 through 3 (Treatment A) and Days 15 through 17 (Treatment B) of each 28-day cycle and once for response evaluation between days 21 and 28 of Cycles 2, 4, and 6. Follow-up visits: Patients with CR, CRu, PR, and SD: Every 60 days after completion of the first MGd dose of Cycle 6 for 1 yr. Patients with PD, RD, or who terminate before study completion: 30 days after the last MGd dose or termination. Safety follow-up: At least 30 days after completion of the last MGd dose. Overall Study Design and Plan: This Phase II trial will evaluate the clinical response rate resulting from the use of MGd in approximately 35 patients with relapsed or refractory indolent NHL. The trial design is based on a Simon 2-stage clinical trial design, 24 Clinical benefit rate, overall progression-free survival, clinical response duration, and safety of this treatment therapy will also be explored. Patients will be monitored for safety (including adverse events [AEs]) throughout the treatment and safety follow-up periods. All patients must have refractory or relapsed indolent NHL as defined by the following: -Refractory disease, defined as disease progression during most recent systemic therapy or no response (less than PR) to most recent systemic therapy -Relapsed disease, defined as progressive disease after having responded to most recent systemic therapy. Patients who meet the eligibility criteria will be enrolled sequentially and treated daily with 6.0 mg/kg MGd on days 1 through 3 (Treatment A) and days 15 through 17 (Treatment B) of each 28-day cycle. Patients will be evaluated for clinical response between days 21 and 28 of Cycles 2, 4, and 6. Patients whose disease has not progressed or relapsed will continue on the study for a maximum of six cycles. Patients with (PD) or (RD) will be terminated from the study. Patients whose disease does not progress and who do not complete Cycle 2 Treatment B and follow-up disease assessments will be replaced. If fewer than two of the 15 patients in Stage 1 exhibit response (CR, CRu, or PR), the study will not proceed to Stage 2. Otherwise, patient enrollment for Stage 2 will begin as soon as the last patient in Stage 1 has been enrolled. In Stage 2, an additional 20 patients will be enrolled and treated following the same treatment regimen and assessment schedule as in Stage 1.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构适用于该中心，这不一定是调查员的机构。评估临床反应率（完全反应[CR]，未确认的完全反应[CRU]和部分反应[PR]），对患有复发性或难治性的非霍奇金淋巴瘤（NHL）二级患者的Motexafin Gadolinium（MGD）； - 评估临床益处的组合率（CR，CRE和PR，稳定疾病[SD]） - 评估无进展的生存率 - 评估临床反应的持续时间 - 评估MGD在该患者人群研究设计中的MGD的安全性和耐受性：一项单臂开放标签，基于Simon 2阶段的II期研究，基于Simon 2 Stage 2阶段的II阶段研究，该研究在Simon 2 Stage Androll in Chate in Stage 15患者中，大约15阶段和20阶段的患者，一名阶段1和20患者，一名2阶段和20名患者，一名2阶段的2阶段，2阶段2和20患者。 这项研究最多包括六个28天的周期或168天，对于表现出临床益处的患者的随访期长达1年。符合资格标准的患者将在第1至第3天（治疗A）和每个28天周期的第1至第3天（治疗A）和第15至17天（治疗B）每天进行依次招募并每天用6.0 mg/kg MGD进行治疗。将评估患者在2、4和6周期的第21至28天之间的反应。将遵循患者，直到疾病进展，疾病复发或治疗完成后一年。该研究将从研究中终止患有进行性疾病（PD）或复发性疾病（RD）的患者。 持续时间：注册将在大约1年内完成。个别患者将参加该研究长达18个月。 研究人群：具有东部合作肿瘤学组（ECOG）性能的成年人，具有0、1或2。端点： - 主要的反应率（CR，CR，CRU，PR）对MMGD的耐受性肿瘤学组（ECOG）的性能得分为0、1或2。临床反应 - 安全性和MGD在治疗不变的NHL研究药物方面的耐受性：MGD 6.0 mg/kg/day每天静脉内施用（IV）一次（iv）在治疗A，第1至3天，第3天和治疗B，第15至17天，每28天周期的15至17天，在30分钟内，在30分钟内。 访问时间表：在初次剂量后的14天内进行筛查。 治疗访问：每天在第1至第3天（治疗A）和每个28天周期的第15至17天（治疗B），一次在周期2、4和6的第21和28天之间进行响应评估。后续访问：CR，CRE，CRE，PR，PR和SD的患者：每60天完成了第6周期6周期的MGD剂量后，每60天后每60天。 PD，RD患者或在学习完成前终止的患者：最后一次MGD剂量或终止后30天。 安全随访：最后一次MGD剂量完成后至少30天。 总体研究设计和计划：这项II期试验将评估大约35例复发或难治性不固定NHL的患者中使用MGD导致的临床缓解率。该试验设计基于Simon 2阶段临床试验设计，24个临床益处率，无进展的生存期，临床反应持续时间以及该治疗疗法的安全性。在整个治疗和安全随访期间，将监控患者的安全性（包括不良事件[AES]）。所有患者必须具有以下确定的难治性或复发性NHL： - 性疾病，被定义为最近的全身治疗过程中疾病进展，或对最新的全身治疗疾病的反应（少于PR），定义为对最近最近系统治疗的进行性疾病定义为进行性疾病。 符合资格标准的患者将在第1至第3天（治疗A）和每个28天周期的第1至第3天（治疗A）和第15至17天（治疗B）每天进行依次招募并每天用6.0 mg/kg MGD进行治疗。将在周期2、4和6的第21和28天之间评估患者的临床反应。疾病尚未进展或复发的患者将继续进行研究，最多六个周期。 （PD）或（RD）患者将从研究中终止。疾病没有进展并且未完成2周期治疗B和随访疾病评估的患者将被取代。如果第1阶段的15例患者中只有不到两名表现出反应（CR，CRE或PR），则该研究将不会继续进行第2阶段。否则，一旦第1阶段的最后一名患者招募了第2阶段的患者入学率。在第2阶段，按照与第1阶段相同的治疗方案和评估时间表，将招募和治疗20名患者。