NCT06084936招募中3 期
A Phase III, Open-Label, Multicenter Randomized Study Evaluating Glofitamab as a Single Agent Versus Investigator's Choice in Patients With Relapsed/Refractory Mantle Cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 182
- 试验地点
- 119
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide with rituximab (R-Len) in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Life expectancy at least 12 weeks
- •Histologically-confirmed MCL, with documentation of either overexpression of cyclin D1 or the presence of t(11:14) within 12 months of study entry
- •Relapsed (disease progression after the last treatment regimen) or refractory (failure to achieve a partial or complete response from the last treatment regimen) disease
- •At least 1 line of prior systemic therapy including a BTK inhibitor and additional systemic therapy option
- •Confirmed availability of tumor tissue, unless deemed unsafe per investigator assessment
- •At least one bi-dimensionally measurable (defined as at least 1.5 cm) nodal lesion, or one bi-dimensionally measurable (at least 1 cm) extranodal lesion, as measured on CT scan
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •Negative HIV test at screening
- •Adequate hematological function
排除标准
- •Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of tocilizumab, 2 months after the final dose of glofitamab, whichever is longer
- •Leukemic, non-nodal MCL
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
- •Contraindication to obinutuzumab or rituximab, and either bendamustine or lenalidomide
- •Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
- •Prior treatment with CAR-T cell therapy
- •Treatment with systemic therapy or BTK inhibitors, or any investigational agent for the purposes of treating cancer within 2 weeks or 5 half-lives (whichever is shorter) prior to first study treatment
- •Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma
- •Current or history of CNS disease, such as stroke, epilepisy, CNS vasculitis, or neurodegenerative disease
- •History of other malignancy that could affect compliance with the protocol or interpretation of results
- •Significant or extensive cardiovascular disease
- •Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment or any major episode of infection within 4 weeks prior to the first study treatment
- •Suspected or latent tuberculosis
- •Positive test for hepatitis B virus (HBV) or hepatitis C virus (HCV)
- •Known or suspected chronic active Epstein-Barr viral infection (EBV)
- •Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
- •Known history of progressive multifocal leukoencephalopathy (PML)
- •Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better
- •Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study
- •Prior solid organ transplantation or allogenic stem cell transplant
- •Eligibility for stem cell transplantation (SCT)
- •Active autoimmune disease requiring treatment
- •Prior treatment with systemic immunosuppressive medications within 2 weeks or five half-lives (whichever is shorter) prior to the first dose of study treatment
- •Corticosteroid therapy within 2 weeks prior to first dose of study treatment
- •Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis
- •Clinically significant history of cirrhotic liver disease
研究组 & 干预措施
BR or R-Len
Active Comparator
Participants will receive bendamustine + rituximab for up to 6 cycles (cycle length = 28 days), or rituximab + lenalidomide (cycle length = 28 days) until disease progression.
干预措施: Bendamustine (Drug)
Glofitamab monotherapy
Experimental
Participants will receive two intravenous (IV) obinutuzumab pretreatments prior to receiving IV glofitamab for 12 cycles (cycle length = 21 days).
干预措施: Tocilizumab (Drug)
BR or R-Len
Active Comparator
Participants will receive bendamustine + rituximab for up to 6 cycles (cycle length = 28 days), or rituximab + lenalidomide (cycle length = 28 days) until disease progression.
干预措施: Tocilizumab (Drug)
BR or R-Len
Active Comparator
Participants will receive bendamustine + rituximab for up to 6 cycles (cycle length = 28 days), or rituximab + lenalidomide (cycle length = 28 days) until disease progression.
干预措施: Lenalidomide (Drug)
Glofitamab monotherapy
Experimental
Participants will receive two intravenous (IV) obinutuzumab pretreatments prior to receiving IV glofitamab for 12 cycles (cycle length = 21 days).
干预措施: Glofitamab (Drug)
Glofitamab monotherapy
Experimental
Participants will receive two intravenous (IV) obinutuzumab pretreatments prior to receiving IV glofitamab for 12 cycles (cycle length = 21 days).
干预措施: Obinutuzumab (Drug)
BR or R-Len
Active Comparator
Participants will receive bendamustine + rituximab for up to 6 cycles (cycle length = 28 days), or rituximab + lenalidomide (cycle length = 28 days) until disease progression.
干预措施: Rituximab (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: From randomization to the first occurrence of disease progression or death from any cause (up to approximately 24 months)
次要结局
- Objective response rate (ORR)(Up to approximately 24 months)
- Change from baseline in physical functioning and fatigue at each cycle as assessed by the European Organization for Research and Treatment (EORTC) core Quality of Life Questionnaire (QLQ-C30)(Up to approximately 24 months)
- Complete response (CR) rate(Up to approximately 24 months)
- Overall survival (OS)(From randomization to death from any cause (up to approximately 24 months))
- Time to deterioration in lymphoma symptoms(From randomization to the first documentation of a 3-point or more decrease in score as assessed by the FACT-Lym lymphoma subscale (LymS) questionnaire (up to approximately 24 months))
- Incidence of anti-drug antibodies (ADAs)(Up to approximately 24 months)
- Investigator-assessed CR rate(Up to approximately 24 months)
- Duration of Complete Response (DOCR)(From the initial occurrence of a documented CR until documented disease progression or death due to any cause, whichever occurs first (up to approximately 24 months))
- Proportion of participants reporting each response option for item GP5 from the Functional Assessment of Cancer Therapy - General (FACT-G) subscale(Up to approximately 24 months)
- Change from baseline in lymphoma symptoms at each cycle as assessed by the FACT-Lym LymS(Up to approximately 24 months)
- Time to deterioration in physical functioning/fatigue(From randomization to a 10-point decrease in physical functioning/10-point increase in fatigue compared to baseline (up to approximately 24 months))
- Investigator-assessed PFS(From randomization to disease progression or death from any cause (up to approximately 24 months))
- Investigator-assessed ORR(Up to approximately 24 months)
- Duration of Response (DOR)(From the initial occurrence of a documented CR until documented disease progression or death due to any cause, whichever occurs first (up to approximately 24 months))
- Proportion of participants experiencing a clinically meaningful improvement (3-point or more increase) in lymphoma symptoms as assessed through use of the FACT-Lym LymS(Up to approximately 24 months)
- Serum concentration of glofitamab(Up to approximately 24 months)
研究者
研究点 (119)
Loading locations...
相似试验
招募中
1 期
A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin LymphomaMature B-Cell Non-Hodgkin LymphomaNCT05533775Hoffmann-La Roche65
已完成
1 期
A Study to Evaluate Glofitamab as Single Agent Administered After Pretreatment With Obinutuzumab in Chinese Patients With Relapsed/Refractory Diffuse Large B-Cell LymphomaLymphomaNCT04657302Hoffmann-La Roche30
进行中（未招募）
3 期
An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell LymphomaNCT06047080Hoffmann-La Roche1,130
已完成
1 期
A Study of Glofitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Non-Hodgkin Lymphomas or With DLBCLNon-Hodgkin LymphomaB-Cell LymphomaNCT03467373Hoffmann-La Roche111
进行中（未招募）
1 期
STUDY EVALUATING EFFECTIVNESS of ANTICD20XCD3 BISPECIFIC ANTIBODIES FOR RELAPSE/REFRACTORY LYMPHOMAS AFTER CART THERAPYEUCTR2020-001985-12-FRYSARC78