NL-OMON54592招募中3 期
Improvement of Outcome in Elderly Patients or Patients not eligible for high-dose chemotherapy with Aggressive Non-Hodgkin Lymphoma in first Relapse or Progression by adding Nivolumab to Gemcitabine, Oxaliplatin plus Rituximab in case of B-cell lymphoma (NIVEAU) - HOVON 153 NHL/ DSHNHL 2015-1 (NIVEAU)
Saarland University, Vice President for Research and Technology0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- all patient >65 years of age or older than 18 years if HCT-CI score > 2
- •- Ineligibility for either autologous or allogeneic stem cell transplantation
- •- Diagnosis of aggressive Non-Hodgkin's lymphoma, based on an excisional biopsy
- •of a lymph node or on an appropriate sample of a lymph node or of an extranodal
- •involvement at initial diagnosis or relapse or progression. The entities
- •treated in the study will be based on
- •the WHO 2017 classification.
- •-Performance status ECOG 0 - 2
- •-Patients must have only one prior chemotherapy regimen including an
- •anthracycline. The last cytotoxic drug must be given at least four weeks before
- •entering the study. Rituximab must be part of the first-line regimen in case of
- •a B-cell lymphoma. Patients may have received prior
- •radiation therapy as part of their first-line therapy.
- •- Men who are sexually active with women of childbearing potential (WOCBP) must
- •use any contraceptive method with a failure rate of less than 1% per year
- •- Written informed consent of the patient
排除标准
- •-Already initiated lymphoma therapy after first relapse or progression (except
- •for the prephase treatment)
- •-Serious accompanying disorder or impaired organ function (except when due to
- •lymphoma involvement)
- •-WBC < 2.5 G/l, Neutrophils < 2 G/l, Platelets < 100 G/l (does not apply if
- •cytopenia is caused by lymphoma)
- •-Prolongation of QTc interval > 450 ms, demonstrated in one electrocardiogram
- •(done as triplicate). This does not apply for patients with a block of the
- •right and/or left bundle branch.
- •-Family history for Long QT-syndrome
- •-Patients with an active, known or suspected autoimmune disease
- •-No requirement for immunosuppressive doses of systemic corticosteroids (except
- •for treatment of lymphoma)
- •-Chronic active hepatitis B or C
- •- HIV-infection
- •- Patients with a severe immunodeficiency
- •- Previous therapy with Nivolumab, Gemcitabine or Oxaliplatin
- •- Patients with a currently active second malignancy other than nonmelanoma
- •skin cancer
- •- CNS involvement of lymphoma (intracerebral, meningeal, intraspinal
- •intradural) or primary CNS lymphoma
- •- Persistent neuropathy grade >2 (NCI CTC-AE v4.03) (unless due to lymphoma
- •involvement)
- •-Pregnancy or breast-feeding women
- •- Women of childbearing potential (WOCBP)
- •- Active serious infections not controlled by oral and/or intravenous
- •antibiotics or antifungal medication
- •- Any medical condition which in the opinion of the investigator places the
- •subject at an unacceptably high risk for toxicities
- •- Lymphomas other than those listed in the inclusion criteria notably indolent
- •Mantle cell lymphoma, Burkitt lymphoma, adult T-cell leukemia/lymphoma.
- •- Persons not able to understand the impact, nature, risks and consequences of
- •(including language barrier)
- •- Persons not agreeing to the transmission of their pseudonymous data
- •- Persons depending on sponsor or investigator
- •- Persons from highly protected groups
- •- Allergies and Adverse Drug Reaction History to study drug components
- •- Participation in another clinical trial with drug intervention within 4 weeks
- •prior to start of the first cycle and during the study. However, participation
- •in a clinical trial of first line therapy of lymphoma is allowed.
研究者
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