EUCTR2016-002272-27-AT进行中（未招募）1 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 - NIVEA
Saarland University0 个研究点目标入组 388 人开始时间: 2019年6月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 388
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
- •1. Age: all patient >65 years of age or > 18 years if not eligible for neither
- •autologous nor allogeneic stem cell transplantation
- •2. Ineligibility for neither autologous nor allogeneic stem cell transplantation as defined as:
- •>65 years of age or
- •older than 18 years if HCT-CI score > 2 (cf. Appendix 24.2) or
- •patients who underwent prior autologous stem cell transplantation and
- •are not eligible for allogeneic stem cell transplantation
- •3. Risk group: All risk groups (IPI 0 to 5)
- •4. Histology: 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 classification62.
- •? Follicular lymphoma grade IIIb
- •? DLBCL, not otherwise specified (NOS)
- •? T-cell/histiocyte-rich large B-cell lymphoma
- •? primary cutaneous DLBCL, leg type
- •? EBV-positive DLBCL, NOS
- •? DLBCL associated with chronic inflammation
- •? primary mediastinal (thymic) large B-cell lymphoma
- •? intravascular large B-cell lymphoma
- •? ALK-positive large B-cell lymphoma
- •? plasmablastic lymphoma
- •? primary effusion lymphoma
- •? HHV8+ DLBCL, NOS
- •? high-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements
- •? high-grade B-cell lymphoma, NOS
- •? B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and
- •classical Hodgkin lymphoma
- •? Aggressive NK cell leukemia
- •? Enteropathy-associated T-cell lymphoma
- •? Hepatosplenic T-cell lymphoma
- •? Primary cutaneous gamma-delta T-cell lymphoma
- •? Peripheral T-cell lymphoma, NOS
- •? Angioimmunoblastic T-cell lymphoma
- •? Anaplastic large cell lymphoma, ALK-positive
- •? Anaplastic large cell lymphoma, ALK-negative
- •? Peripheral T-cell lymphoma with TFH phenotype
- •? Monomorphic epitheliotropic intestinal T-cell lymphoma
- •? Subcutaneous panniculitis-like T-cell lymphoma
- •5. Performance status: Performance status ECOG 0 – 2. Also patients with performance
- •status 0 – 2 are eligible when assessed after prephase treatment.
- •The performance status of each patient should be assessed before
- •the initiation and after the end of prephase treatment which, as
- •experience has shown, can result in its significant improvement. A
- •definition of the performance status is provided in Appendix 24.3.
- •6. Previous therapy: Patients must have only one prior chemotherapy regimen including an
- •anthracycline. The last cytotoxic drug must be given at least four
- •weeks prior randomization. Rituximab must be part of the first-line
- •regimen in case of B-cell lymphoma (except for primary CD20-
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排除标准
- •1. Already initiated lymphoma therapy after first relapse or progression (except for the
- •prephase treatment, cf. 8.6.1).
- •2. Serious accompanying disorder or impaired organ function (except when due to lymphoma
- •involvement), in particular:
- •? heart: angina pectoris CCS >2, cardiac failure e.g. NYHA >2
- •? liver: total bilirubin >1.5 times the upper reference limit (except
- •subjects with Gilbert Syndrome, who can have total bilirubin
- •<51 µmol/l), aspartate transaminase (AST) or alanine
- •transaminase (ALT) >3 x institutional upper reference limit
- •? kidney: creatinine clearance < 30 ml/min
- •3. WBC < 2.5 G/l, Neutrophils <2 G/l, Platelets <100G/l (does not apply if cytopenia is caused
- •by lymphoma)
- •4. 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.
- •5. Family history for Long QT-syndrome
- •6. Patients with an active, known or suspected autoimmune disease. Subjects are permitted
- •to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to
- •autoimmune condition only requiring hormone replacement, psoriasis not requiring
- •systemic treatment, or conditions not expected to recur in the absence of an external
- •7. There must also be no requirement for immunosuppressive doses of systemic
- •corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study
- •drug administration (except for treatment of lymphoma).
- •8. Chronic active hepatitis B or C as defined either HBs Ag positive or HBc Ac positive with
- •detectable viral DNA or hepatitis C virus ribonucleic acid positive.
- •9. HIV-infection
- •10. Patients with a severe immunodeficiency
- •11. Previous therapy with Nivolumab, Gemcitabine or Oxaliplatin.
- •12. Patients with a currently active” second malignancy other than non-melanoma skin cancer.
- •Patients are not considered to have a currently active” malignancy if they have completed
- •therapy since 6 months and are considered by their physician to be less than 30% risk of
- •relapse within one year.
- •13. CNS involvement of lymphoma (intracerebral, meningeal, intraspinal intradural) or primary
- •CNS lymphoma
- •14. Persistent neuropathy grade >2 (NCI CTC-AE v4.03) (unless due to lymphoma
- •involvement)
- •15. Pregnancy or breast-feeding women
- •16. Women of childbearing potential (WOCBP). A WOCBP is defined as any female who has
- •experienced menarche and who has not undergone surgical sterilization (hysterectomy or
- •bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as
- •12 months of amenorrhea in a woman over 45 in the absence of other biological or
- •physiological causes. In addition, women under the age of 62 must have a documented
- •serum follicle stimulating hormone (FSH) level higher than 40 mIU/mL.
- •17. Active serious infections not controlled by oral and/or intravenous antibiotics or antifungal
- •18. Any medical condition which in the opinion of the investigator places the subject at an
- •unacceptably high risk for toxicities
- •19. Lymphomas other than those listed in the inclusion criteria notably indolent lymphoma,
- •Mantle cell lymphoma, Burkitt lymphoma, adult T-cell leukemia/lymphoma.
- •20. Persons not able to understand the impact, nature, risks and consequences of the trial
- •(including language barrier)
- •21. Persons not agreeing to the transmission of their pseudonymous data
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