A pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B-cell lymphoma (R-R DLBCL), who are not eligible for high-dose chemotherapy and autologous stem cell transplantation
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 168
- 试验地点
- 52
- 主要终点
- Event-free survival (EFS), defined as the time between the date of randomisation and the date of objective disease progression, failure to achieve partial response (PR) or complete response (CR) at or beyond Week 8 after randomisation leading to a new anti-lymphoma therapy or death of any cause, whichever occurs first, based on independent review committee (IRC) assessment.
研究概览
简要总结
The primary objective is to determine superiority of MB-CART2019.1 treatment compared to standard of care (SoC) therapy with R-GemOx (rituximab, gemcitabine and oxaliplatin) with respect to event-free survival in second-line therapy in participants with R-R DLBCL, who are non-eligible for high-dose chemotherapy and autologous stem cell transplantation (ASCT).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Histologically proven DLBCL and associated subtypes, according to the World Health Organization (WHO) 2016 classification
- •Men with non-pregnant WOCBP partners must agree to use highly effective contraceptive measures
- •In the opinion of the investigator, the participant must be able to comply with all study-related procedures, medication use and evaluations
- •Mental capacity and legal ability to consent to participation in the clinical study.
- •Relapsed or refractory disease after first-line chemoimmunotherapy
- •Participants must have received adequate first-line therapy containing at least the combination of an anthracycline-based regimen and rituximab (anti-CD20 monoclonal antibody).
- •Archival paraffin-embedded tumour tissue acquired ≤ 2 years (preferred: ≤ 2 months) prior to screening for the central pathology review to confirm DLBCL diagnosis must be made available for participation in this study. The lesion must be measurable (nodes > 1.5 cm in the long axis; extranodal lesions > 1 cm in the long axis) and positive on a positron emission tomography scan.
- •Participants deemed ineligible to receive HDC followed by ASCT based on the treating physician’s assessment
- •Age ≥ 18 years
- •Measurable disease according to Lugano criteria. The lesion must be measurable (nodes > 1.5 cm in the long axis; extranodal lesions > 1 cm in the long axis) and positive on a positron emission tomography scan
- •Estimated life expectancy of > 3 months for other reasons than the primary disease
- •Women of childbearing potential (WOCBP) must agree to use highly effective contraceptive measures
排除标准
- •Contraindications for R-GemOx, BR plus polatuzumab vedotin, cyclophosphamide and fludarabine as judged by the treating physician.
- •Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy.
- •Participants who have received more than one line of treatment for DLBCL or associated subtypes.
- •Prior haematopoietic stem cell transplantation (HSCT; as first-line consolidation) < 3 months at the time of leukapheresis.
- •ECOG performance status > 2
结局指标
主要结局
Event-free survival (EFS), defined as the time between the date of randomisation and the date of objective disease progression, failure to achieve partial response (PR) or complete response (CR) at or beyond Week 8 after randomisation leading to a new anti-lymphoma therapy or death of any cause, whichever occurs first, based on independent review committee (IRC) assessment.
Event-free survival (EFS), defined as the time between the date of randomisation and the date of objective disease progression, failure to achieve partial response (PR) or complete response (CR) at or beyond Week 8 after randomisation leading to a new anti-lymphoma therapy or death of any cause, whichever occurs first, based on independent review committee (IRC) assessment.
次要结局
- Progression-free survival (PFS), defined as the time between the date of randomisation and the date of objective disease progression or death of any cause, whichever occurs first, based on IRC assessment.
- Best complete response rate (BCRR), defined as the proportion of participants with at least one CR assessment until Week 24 in the MB-CART2019.1 arm and Week 26 in the comparator arm based on IRC assessment.
- Duration of complete response (DOCR), defined as the time between the date of a first CR and the date of assessment of objective disease progression or the date of death of any cause, whichever occurs first, based on IRC assessment.
- Overall survival (OS), defined as time between the date of randomisation and the date of death of any cause.
研究者
Clinical Trial Desk
Scientific
Miltenyi Biomedicine GmbH