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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 目的：评价复发或难治性惰性非霍奇金淋巴瘤(NHL)患者对莫特沙芬(MGD)的临床有效率(完全缓解[CR]、未确认完全缓解[CRU]和部分缓解[PR])。 次要的； -评估综合临床受益率(CR、CRU和PR，稳定 疾病[SD]) -评估无进展生存 -评估临床反应持续时间 -评估MGD在该患者群体中的安全性和耐受性 总体研究设计和计划： 这项第二阶段试验将评估在大约35名复发或难治性惰性非霍奇金淋巴瘤患者中使用MGD的临床应答率。试验设计基于SIMON两阶段临床试验设计，还将探讨这种治疗方法的24临床受益率、总体无进展存活率、临床反应持续时间和安全性。将在整个治疗和安全随访期内监测患者的安全性(包括不良事件[AE])。 所有患者必须患有难治性或复发性惰性非霍奇金淋巴瘤，其定义如下： -难治性疾病，定义为在最近的系统治疗期间疾病进展或对最近的系统治疗无反应(低于PR) -复发性疾病，定义为对最近的系统治疗有反应后的进展性疾病。 符合资格标准的患者将按顺序入选，并在每个28天周期的第1至3天(治疗A)和第15至17天(治疗B)每天服用6.0 mg/kg的MGD。 将在第2、4和6周期的第21至28天对患者的临床反应进行评估。未进展或复发的患者将继续进行研究，最多6个周期。患有(PD)或(RD)的患者将被从研究中终止。疾病没有进展和没有完成周期2治疗B和后续疾病评估的患者将被替换。 如果第一阶段的15名患者中有不到两名患者出现应答(CR、CRU或PR)，研究将不会进入第二阶段。否则，一旦第一阶段的最后一名患者入选，第二阶段的患者登记就会开始。在第二阶段，将按照与第一阶段相同的治疗方案和评估时间表，再招募20名患者进行治疗。

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.