ISRCTN11965217已完成2 期
A phase II study of atezolizumab with rituximab, gemcitabine and oxaliplatin in patients with relapsed or refractory diffuse large b-cell lymphoma who are not candidates for high-dose therapy
niversity Hospital Southampton NHS Foundation Trust0 个研究点目标入组 53 人开始时间: 2017年11月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
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
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 05/07/2019:
- •1 Histologically proven CD20 +ve diffuse large B-cell lymphoma (including transformation of previous low-grade lymphoma and primary mediastinal B-cell lymphoma), preferably with sufficient diagnostic material, available to forward to the Haematological Malignancies Diagnostic Service (HMDS). (See screening procedure for details on biopsy requirements)
- •2. Refractory to, or relapsed following, first-line or second-line treatments with rituximab concurrently with anthracycline or anthracenedione-based chemotherapy (etoposide or gemcitabine allowed if comorbid). Patients who have received further lines of treatment may be included.
- •Refractory disease must fulfil one of the following:
- •2.1 Continuing partial response (PR) from termination of first-line treatment. It is strongly recommended the lymphoma be reconfirmed by biopsy however, if these procedures are deemed to be inappropriate, the CI may determine eligibility following review of the imaging results and disease history.
- •2.2 Continuing stable disease (SD) from termination of first-line treatment. Reconfirmation of the lymphoma by biopsy (preferred) is recommended but not mandatory.
- •2.3 Progressive disease (PD). Biopsy or reconfirmation of the lymphoma is recommended but not mandatory.
- •3. Not eligible for high-dose therapy with peripheral blood progenitor cell rescue at Investigator discretion as a result of: (a) Age; (b) Co-morbidity; (c) Previous HDT.Rationale to be clearly documented on eCRF and medical notes.
- •4. Baseline FDG-PET scans must demonstrate positive lesions compatible with CT defined anatomical tumour sites.
- •5. CT/PET scan showing at least: 2 or more clearly demarcated lesions/nodes with a long axis >1.5cm and short axis =1.0cm
- •OR 1 clearly demarcated lesion/node with a long axis >2.0cm and short axis =1.0cm.
- •6. Resolution of toxicities from previous therapy to a grade that in the opinion of the investigator does not contraindicate study participation.
- •7. Patients aged 16 years or over.
- •8. Willingness to participate in appropriate pregnancy prevention measures.
- •8.1Female patients who are fertile and of childbearing potential must have a negative serum or urine pregnancy test during screening (within 14 days prior to the start of trial treatment) and agree to use two highly effective forms of contraception (oral, injected or implanted hormonal contraception and condom; an intra-uterine device and condom) effective from the first administration of all study drugs, throughout the trial and for 12 months after last dose of study therapy are considered eligible. Unless they are surgically sterile or = 2 years after the onset of menopause.
- •8.2 Male patients with partners of child-bearing potential who agree to take measures not to father children by using two forms of highly effective contraception (oral, injected or implanted hormonal contraception and condom; an intra-uterine device and condom) effective from the first administration of all study drugs, throughout the trial and for 12 months after last dose of study therapy are considered eligible. Male subjects must also refrain from donating sperm during this period. Unless they are surgically sterile.
排除标准
- •Current participant exclusion criteria as of 05/07/2019:
- •1 Received any of the following treatments within two weeks prior to start of study therapy (unless otherwise stated):
- •1.1 Anti-cancer cytotoxics (excluding corticosteroids)
- •1.2 Radiotherapy unless it is to a limited field to control life/organ-threatening symptoms.
- •2. DLBCL that is refractory to or relapsed within 3 months of a gemcitabine regimen for DLBCL
- •3. Major surgery within 4 weeks of registration.
- •4. Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half-lives or 4 weeks prior to registration.
- •5. History of stroke or intracranial haemorrhage within 6 months prior to registration.
- •6. Pre-existing peripheral neuropathy grade >2.
- •7. Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to registration, congestive heart failure (NYHA III-IV), a current LVEF of <40%
- •8. Significant concurrent, uncontrolled medical condition that in the opinion of the investigator contraindicates participation in this study
- •9. Known lymphoma involvement of the CNS.
- •10. Known or suspected hypersensitivity to study treatments that in the opinion of the investigator contraindicates their participation. Patients with known history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug induced pneumonitis or idiopathic pneumonitis, or evidence of active pneumonitis will be excluded from study participation.
- •11. Known HIV positivity; positive serology for Hep B (defined as positivity for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (anti-HBc)) or C; chronic or current infectious disease (except evidence of prior vaccination).
- •12. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 2 weeks of the start of Cycle 1. Suspected active or latent tuberculosis needs to be confirmed by positive interferon gamma (IFN-?) release assay.
- •13. Other past or current malignancy within 2 years prior to registration unless in the opinion of the investigator it does not contraindicate participation in the study. Subjects who have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma, are eligible.
- •14. Screening laboratory values:
- •14.1 Platelets <75x109/L (unless due to lymphoma involvement of the bone marrow)
- •14.2 Neutrophils <1.0x109/L (unless due to lymphoma involvement of the bone marrow)
- •14.3 Creatinine clearance <60mL/min (should be calculated using Cockcroft and Gault equation)
- •14.4 Creatinine >2.0 times upper normal limit (unless due to lymphoma or unless creatinine clearance >60mL/min)
- •14.5 Total bilirubin >1.5 times upper normal limit (unless due to lymphoma or a known history of Gilbert’s disease, no higher than >3 times upper normal limit)
- •14.6 ALT/AST >2.5 times upper normal limit (unless due to lymphoma, no higher than >5 times upper normal limit)
- •14.7 Alkaline phosphatase >2.5 times upper
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