EUCTR2016-003579-22-LV进行中（未招募）1 期
A PHASE II STUDY EXPLORING THE SAFETY AND EFFICACY OF ATEZOLIZUMAB ADMINISTERED IN COMBINATION WITH OBINUTUZUMAB OR RITUXIMAB ANTI-CD20 THERAPY IN PATIENTS WITH RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA, MARGINAL ZONE LYMPHOMA AND WALDENSTRÖM MACROGLOBULINEMIA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Ability to comply with the protocol
- •- Age >= 18 years
- •- Histologically documented, CD20 positive, relapsed or refractory MCL, MZL and WM. Refractory is defined for the 3 indications as having relapsed during or within 6 months after the last dose of the previous treatment. . For WM patients, the diagnosis of relapse/refractory will be accompanied by evidence of reappearance of monoclonal IgM protein and/or recurrence of bone marrow involvement, lymphadenopathy/splenomegaly with symptoms attributable to active disease Where ibrutinib is available in the selected country, patients with MCL or WM must have relapsed or become refractory to its benefits, or become intolerant of ibrutinib. All other patients must have failed at least 1 prior line of systemic treatment.
- •- Bone marrow biopsy and/or other sites of disease at screening for tumor staging and response evaluation
- •- ECOG performance status of 0, 1 or 2
- •- Life expectancy>=12 weeks
- •- For mantle cell lymphoma (MCL) and nodal marginal zone lymphoma (MZL), at least one bi-dimensionally measurable lesion>=1.5 cm in its largest dimension by Computed Tomography scan or MRI, as defined by Revised Response Criteria for Malignant Lymphoma
- •- Adequate hematologic and end-organ function
- •- For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or to use single highly effective or combined contraceptive methods that result in a failure rate of < 1% per year, starting at least 28 days prior to Day 1 of Cycle 1, during the treatment period for at least 18 months after the last dose of combination therapy
- •- For women of childbearing potential (including premenopausal women who have had tubal ligation and women not meeting the definition of postmenopausal), a negative serum pregnancy test result on Day 1 of Cycle 1 prior to dosing. For all other women, documentation must be present in the medical history confirming that the patient is not of childbearing potential.
- •- For men, agreement to remain abstinent or to use a condom plus an additional contraceptive method that together result in a failure rate of 1% per year during the treatment period and for at least 3 months after the last dose of combination therapy
- •- Tumor tissue fresh sample preferred, archival tissue is acceptable (only if a fresh sample is not available).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 84
排除标准
- •- Any approved anticancer therapy or hormonal therapy within 3 weeks prior to initiation of study treatment. Any radiotherapy within 4 weeks prior to initiation of study treatment.
- •- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or 5 half-lifes prior to enrolment, whichever is longest.
- •- Known Central nervous system lymphoma, leptomeningeal lymphoma, or histologic evidence of transformation to a high-grade or diffuse large B-cell lymphoma
- •- Uncontrolled tumor-related pain
- •- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures; patients with indwelling catheters are eligible
- •- Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
- •- History of other malignancy
- •- History of severe allergic or anaphylactic or other hypersensitivity reactions to chimeric or humanized or murine monoclonal antibodies or fusion proteins or murine proteins or known sensitivity or allergy to murine products
- •- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection or any major episode of infection requiring treatment with intravenous (IV) antibiotics or hospitalization within 4 weeks of the start of Cycle (C) 1
- •- Regular treatment with corticosteroids within the 4 weeks prior to the start of C1
- •General Medical Exclusions
- •- Pregnant and lactating women, or intending to become pregnant during the study. Women who are not postmenopausal or surgically sterile must have a negative serum pregnancy test result on Day (D) 1 of C1 prior to dosing.
- •- History of autoimmune disease
- •- Other serious underlying medical conditions, which, in the Investigator’s judgment, could impair the ability of the patient to participate in the study
- •- Significant cardiovascular disease, such as cardiac disease (New York Heart Association Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina
- •- Patients with history of confirmed progressive multifocal leukoencephalopathy
- •- Patients with prior allogeneic bone marrow transplantation (allo BMT) allogeneic stem cell transplant (ASCT), or prior solid organ transplantation
- •- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis per chest CT scan at screening
- •- Serum albumin < 2.5 g/dL
- •- Positive test for HIV, human T-lymphotrophic 1 virus, and hepatitis B or C
- •- Active tuberculosis
- •- Received therapeutic IV antibiotics within 4 weeks prior to C1D1. Received oral antibiotics within 7 days prior to C1D1 (except for tumor fever). Patients receiving prophylactic antibiotics are eligible.
- •- Major surgical procedure other than for diagnosis within 28 days prior to C1D1
- •- Administration of a live, attenuated vaccine within 4 weeks before C1D1
- •Exclusion Criteria Related to Medications
- •- Known hypersensitivity to obinutuzumab, rituximab or atezolizumab or their formulation excipients
- •- Prior treatment with obinutuzumab or atezolizumab, or anti progressive disease (PD)-1 or programmed death-ligand 1 (PDL-1) antibodies
- •- Fludarabine or Campath® within 12 months prior to study entry
- •- Prior treatment with CD137 agonists or immune checkpoint bloc
研究者
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