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: 7605205
• 负责人: RAJ ADVANI
• 金额: $ 1.05万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-15 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605205
• 关键词: Adverse event; Clinical; Clinical Trials Design; Computer Retrieval of Information on Scientific Projects Database; Daily; Disease; Disease Progression; Eligibility Determination; Enrollment; Exhibits; Funding; Grant; In complete remission; Indolent; Institution; Monitor; Motexafin Gadolinium; Non-Hodgkin' s Lymphoma; Patients; Phase II Clinical Trials; Population; Progression-Free Survivals; Progressive Disease; Rate; Recurrent disease; Refractory; Refractory Disease; Relapse; Research; Research Design; Research Personnel; Resources; Safety; Schedule; Source; Stable Disease; Staging; Systemic Therapy; Treatment Protocols; United States National Institutes of Health; base; day; design; follow-up; partial response; response

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 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 [AE) 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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。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。列出的机构是 对于中心，这不一定是调查员的机构。 评估临床反应率（完全反应[CR]，未经证实的完全反应[CRU]和部分反应[PR]），对患有复发或难治性非霍奇金淋巴瘤（NHL）患者的Motexafin Gadolinium（MGD）（MGD） 次级 - 评估临床福利率（CR，CRU和PR，稳定） 疾病[SD]） - 评估无进展的生存 - 评估临床反应持续时间 - 评估该患者人群中MGD的安全性和耐受性 整体研究设计和计划： 该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。 在整个治疗期间，将监控患者的安全性（包括不良事件[AE）。 所有患者必须具有以下确定的耐火或懒惰的NHL： - 性疾病，定义为最近的全身治疗过程中的疾病进展，或者对最近的全身治疗的反应（小于PR） - 对最近的全身治疗作出反应后，被定义为进行性疾病的疾病。 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。