NCT05846750招募中2 期
A Prospective, Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of Obinutuzumab(GA101) in Combination With Lenalidomide in Relapsed and Refractory(R/R) Marginal Zone Lymphoma (MZL)
Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2022年11月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Overall Remission Rate(ORR)
研究概览
简要总结
This is a prospective, multicenter clinical study that will enroll 59 patients with relapsed and refractory (R/R) MZL. The study is designed to evaluate the efficacy and safety of the combination of obinutuzumab and lenalidomide in the treatment of relapsed and refractory marginal zone lymphoma (MZL).
详细描述
Marginal zone lymphoma (MZL) is incurable, and the vast majority of patients with MZL eventually face disease relapse or progression.
There is no standard second-line treatment for relapsed/refractory MZL, and the synergistic effect of obinutuzumab and lenalidomide has been demonstrated in other indolent lymphomas.
The aim of this trial is to investigate the efficacy and safety of the combination of obinutuzumab (GA101) and lenalidomide in the treatment of R/R marginal zone lymphoma in order to find a safe and effective option for this type of disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Signed Informed Consent Form
- •Age ≥18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •Histologically confirmed MZL. have a definite diagnosis of MZL
- •Prior treatment with at least one line of systemic lymphoma including prior immunotherapy or chemoimmunotherapy
- •At least one bi-dimensionally measurable nodal lesion (> 1.5 cm in greatest diameter on CT scan or MRI) OR at least one bi-dimensionally measurable extranodal lesion (> 1.0 cm in greatest diameter on CT scan or MRI)
- •Need for systemic therapy as assessed by the investigator
- •Life expectancy ≥ 3 months
- •Adequate blood function (except for abnormalities considered by the investigator to be due to the underlying disease of lymphoma), defined as follows:
- •Hemoglobin ≥ 7 g/dL; Absolute neutrophil count ≥ 1.0 × 109/L; Platelet count ≥ 50 x 109/L
- •Normal laboratory values:
- •Creatinine clearance ≥ 30 mL/min; Glutathione transaminase(AST) or glutathione aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN); Serum bilirubin ≤ 2 × ULN (≤ 3 × ULN in patients with Gilbert's syndrome)
- •For men who are not surgically sterile: Agree to use barrier contraception during treatment and for at least 3 months after the last dose of obinutuzumab or lenalidomide or as required by institutional guidelines, whichever is longer. In addition, male patients must agree to have their partner use an alternative method of contraception (e.g., oral contraceptive, intrauterine device, barrier method, or spermicide)
- •For women who are not surgically sterile: use two appropriate methods of contraception, such as oral contraceptives, intrauterine device, or barrier methods, in combination with spermicide for at least 28 days prior to agreeing to start of study medication, during treatment and for at least 12 months after the last dose of either obinutuzumab or lenalidomide, or as required by institutional guidelines, whichever is longer -
排除标准
- •Patients who are refractory or resistant to lenalidomide or obinutuzumab, refractory is defined as no response (PR or CR) after the start of treatment, or relapse within 6 months (≤ 2 cycles of prior lenalidomide or obinutuzumab and no exclusion of treatment change for non-refractory reasons)
- •History of serious allergic or anaphylactic reactions to monoclonal antibody therapy
- •Known hypersensitivity to any of the study drugs
- •Known sensitivity to murine products
- •Previous ≥ Grade 3 allergic reactions/Hypersensitivity to thalidomide
- •History of erythema multiforme, Grade 3 rash, or blisters following prior immunomodulatory derivative therapy
- •Histologically transformed, highly malignant or diffuse large B-cell lymphoma
- •Central nervous system or meningeal involvement by lymphoma
- •Contraindications for the investigational medical product included in the study treatment regimen
- •Positive test for chronic hepatitis B infection (defined as positive HBsAg serology)
- •Hepatitis C positive (hepatitis C virus antibody serology)
- •HIV or Human T-Lymphocytic Leukemia Virus 1 (HTLV1) positive
- •Evidence of any serious, uncontrolled co-morbidities that affect compliance with the protocol or interpretation of results, including but not limited to significant cardiovascular disease (e.g., New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmias, or unstable angina), or significant pulmonary disease (including history of obstructive pulmonary disease or bronchospasm)
- •Infection caused by known active bacteria, viruses, fungi, or other microorganisms (other than fungal infection of the nail bed), or any major infection requiring intravenous antibiotics or hospitalization (completion of the entire course of antibiotics, except for neoplastic fever) within 4 weeks prior to enrollment
- •Prior malignancy other than lymphoma, unless the subject has a disease-free survival of ≥ 5 years
- •Pregnant or lactating women.
- •Have ≥ Grade 2 neuropathy
- •Participation in another clinical trial using a pharmacological intervention during the trial or within 28 days prior to Cycle 1
- •Corticosteroids within 4 weeks of enrollment, unless administered at a dose equivalent to ≤ 30 mg/day prednisone (within 4 weeks)
- •Past history of progressive multifocal leukoencephalopathy (PML)
- •Live vaccines within 28 days of treatment start
- •History of solid organ transplantation
- •Presence of any serious illness or abnormality in the clinical laboratory test results that, in the opinion of the investigator, would make the patient unable to safely participate and complete this study, or affect protocol compliance or interpretation of results
研究组 & 干预措施
Obinutuzumab and lenalidomide
Experimental
Patients will be treated with obinutuzumab and lenalidomide for 6 cycles as induction, and the patients who achieve at least a partial response after 6 cycles of induction therapy will be eligible to enter the maintenance phase for 2 years
干预措施: Obinutuzumab (Drug)
Obinutuzumab and lenalidomide
Experimental
Patients will be treated with obinutuzumab and lenalidomide for 6 cycles as induction, and the patients who achieve at least a partial response after 6 cycles of induction therapy will be eligible to enter the maintenance phase for 2 years
干预措施: lenalidomide (Drug)
结局指标
主要结局
Overall Remission Rate(ORR)
时间窗: 24 weeks
Disease response evaluation after 6 cycles will be used to determine the overall remission rate
次要结局
- 2-year Progression Free Survival (PFS24):(up to 4.5 years)
- Overall survival (OS)(up to 4.5 years)
- Complete Response Rate (CR)(24 weeks)
- 2-year Event-Free Survival (EFS24)(up to 4.5 years)
研究者
研究点 (1)
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