2023-503206-37-00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
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
- 39
- 试验地点
- 17
- 主要终点
- PFS as determined by the Blinded independent Review Committee (BIRC)
研究概览
简要总结
To evaluate the efficacy of glofitamab monotherapy compared with an investigator’s choice of bendamustine with rituximab (BR) or lenalidomide with rituximab (R-Len) with respect to progression-free survival (PFS)
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •PET-positive disease at screening (Deauville score of 4 or 5) according to the “Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification” with at least one target FDG-avid lesion In rare cases of non-FDG-avid MCL with at least one measurable lesion located in an area suitable for biopsy, such as the gastrointestinal tract and a biopsy can be obtained to confirm a histological diagnosis, a participant may be eligible
- •Histologically-confirmed MCL, demonstrating either overexpression of cyclin D1 or the presence of t(11:14) within 12 months of study entry
- •Relapsed or refractory disease
- •At least one (>= 1) line of prior systemic therapy: - Inclusion of BTK inhibitor Prior therapy must have included a BTK inhibitor plus another systemic therapy option (e.g., a regimen containing a CD20 monoclonal antibody, prior chemotherapy, targeted agent therapy such as bortezomib, etc.) – Progression or Relapse: Participants must have progressed or relapsed at any time on BTK inhibitor therapy, or failed to achieve a partial response (PR) within 12 weeks of BTK inhibitor therapy – Exclusion of BTK Inhibitor Intolerance: Participants intolerant to BTK inhibitor therapy who are unable to complete at least 12 weeks of BTK inhibitor therapy should be excluded – Local Therapies: Local therapies (e.g., radiotherapy) will not be considered as lines of therapy
- •Adequate renal function, defined as an estimated creatinine clearance ≥ 30 mL/min
- •Adequate hematologic function
排除标准
- •History of other malignancy that could affect compliance with the protocol or interpretation of results - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the compliance of or safety or efficacy assessment of the investigational regimen are eligible for this study
- •Leukemic, non-nodal MCL
- •Prior solid organ transplantation, prior allogeneic stem cell transplant
- •Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3 and also treatment with chimeric antigen receptor T-cell (CAR-T) cell therapy
- •Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment or history of CNS lymphoma
- •Presence of severe active bacterial, viral, fungal, mycobacterial, parasitic, or other infections at the time of study enrolment. Participants must have recovered from any severe or potentially serious infection (as assessed by the investigator) at least 2 weeks before the first study treatment
- •Clinically significant history of cirrhotic liver disease
研究组 & 干预措施
RoActemra 20 mg/mL concentrate for solution for infusion, RoActemra 20 mg/mL concentrate for solution for infusion
Test
干预措施: RoActemra 20 mg/mL concentrate for solution for infusion (Drug)
Gazyvaro 1,000 mg concentrate for solution for infusion.
Test
干预措施: Gazyvaro 1,000 mg concentrate for solution for infusion. (Drug)
MabThera 500 mg concentrate for solution for infusion
Comparator
干预措施: MabThera 500 mg concentrate for solution for infusion (Drug)
结局指标
主要结局
PFS as determined by the Blinded independent Review Committee (BIRC)
PFS as determined by the Blinded independent Review Committee (BIRC)
次要结局
- BIRC-assessed CR rate
- BIRC-assessed ORR
- OS
- Time to deterioration in physical functioning and fatigue as assessed by the European Organization for Research and Treatment of Cancer (EORTC) quality of life (QoL)-C30
- Investigator-assessed PFS
- Investigator-assessed CR rate
- Investigator-assessed OR rate
- Investigator-assessed DOCR
- Investigator-assessed DOR
- BIRC-assessed DOCR
- BIRC-assessed DOR
- Investigator-assessed EFS
- Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 grading scale, except cytokine-release syndrome (CRS), immune effector cell associated neurotoxicity syndrome (ICANS) and hemophagocytic lymphohistiocytosis (HLH) which will be graded using American Society for Transplantation and Cellular Therapy (ASTCT) grading criteria (Lee et al., 2019; Hines et al., 2023
- Change from baseline in selected vital signs
- Change from baseline in selected clinical laboratory test results
- Frequency, severity, and interference of side effects as assessed by the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
- Proportion of participants reporting each response option for item General Population, Question 5 (GP5) from the Functional Assessment of Cancer Therapy General (FACT-G) at each assessment timepoint by treatment arm
- Time to deterioration in lymphoma symptoms, defined as the time from randomization to the first documentation of a 3-point or more decrease in score as assessed by the Functional Assessment of Cancer Therapy Lymphoma Lymphoma Subscale (FACT-Lym LYMS) questionnaire
- 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
- Proportion of participants experiencing a clinically meaningful improvement in physical functioning (10-point or more increase) and/or fatigue (10-point or more decrease) as assessed by the EORTC QLQ-C30
- Change from baseline in physical functioning, fatigue, and lymphoma symptoms at each cycle as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and FACT-Lym LYMS
- Serum concentration of glofitamab at specified timepoints
- Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (17)
Loading locations...
相似试验
招募中
2 期
Glofitamab Combined With Lenalidomide in High Risk Patients With Relapsed or Refractory Mantle Cell LymphomaMCLNCT07460362Peking University Third Hospital43
招募中
2 期
Study With Glofitamab in Patients With MCL and Inadequate Response or Relapse Following CAR T-cell TherapyMantle Cell LymphomaNCT07453095Fondazione Italiana Linfomi - ETS41
尚未招募
1 期
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell LymphomaNCT07444710National Cancer Institute (NCI)16
尚未招募
4 期
Iguratimod 25mg BD or Leflunomide 20mg OD either of any one drug is given to RA patients, who has shown no response or inadequate response to Methotrexate and HCQS. Hence study is done to evaluate the effectiveness of Iguratimod or Leflunomide in Rheumatoid Arthritis patientsCTRI/2025/02/080435ChanRe Rheumatology and Immunology Center and Research110
招募中
4 期
A Study to evaluate the safety and efficacy of Guselkumab injected Subcutaneously in Indian Participants for treatment in Psoriatic Arthritis (PsA)CTRI/2025/07/091428Johnson and Johnson Private Limited100