NL-OMON52670已完成2 期
Autologous Dendritic Cells Loaded with Allogenic Tumor Lysate for Surgically Resected Pancreatic Cancer Patients (REACtiVe trial). - REACtiVe
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
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
- •Surgically resected pancreatic cancer.
- •Completed post-operative standard treatment. Patients who did not complete
- •standard of care due to toxicity or who are not able to start standard of care
- •due to specific reasons are allowed to participate in the study after approval
- •of the coordinating investigator.
- •Patients who received standard of care post-operative treatment must be
- •included within six months after completion of treatment. Patients who did not
- •receive standard of care post-operative treatment must be included within six
- •months after resection.
- •No disease activity as assessed by radiological imaging.
- •Patients must be at least 18 years old and must be able to give written
- •informed consent.
- •Patients must be ambulatory (WHO-ECOG performance status 0,1 or 2) and in
- •stable medical condition.
- •Patients must have normal organ function and adequate bone marrow reserve:
- •absolute neutrophil count >1.0 x 10E9/l, platelet count > 100 x 10E9/l, and Hb
- •> 6.0 mmol/l (as determined during screening).
- •Women of childbearing potential must have a negative serum pregnancy test at
- •screening and a negative urine pregnancy test just prior to the first study
- •drug administration on Day 1, and must be willing to use an effective
- •contraceptive method (intrauterine devices, hormonal contraceptives,
- •contraceptive pill, implants, transdermal patches, hormonal vaginal devices,
- •infusions with prolonged release) or true abstinence (when this is in line with
- •the preferred and usual lifestyle)* during the study and for at least 12 months
- •after the last study drug administration.
- •*True abstinence is acceptable when this is in line with the preferred and
- •usual lifestyle of the subject. Periodic abstinence (such as calendar,
- •ovulation, symptothermal, post-ovulation methods) and withdrawal are not
- •acceptable methods of contraception.
- •Men must be willing to use an effective contraceptive method (e.g. condom,
- •vasectomy) during the study and for at least 12 months after the last study
- •drug administration.
- •Positive DTH skin test (induration > 2mm after 48 hrs) against at least one
- •positive control antigen tetanus toxoid (see section 8.3 for DTH skin test
- •procedure).
- •Ability to return to the hospital for adequate follow-up as required by this
- •Written informed consent according to ICH-GCP.
排除标准
- •Medical or psychological impediment to probable compliance with the protocol.
- •Current or previous treatment with immunotherapeutic agents.
- •Current use of steroids (or other immunosuppressive agents). Patients must
- •have had 6 weeks of discontinuation and must stop any such treatment during the
- •time of the study. Prophylactic usage of dexamethasone during chemotherapy is
- •excluded from this 6 weeks interval.
- •Prior malignancy except adequately treated basal cell or squamous cell skin
- •cancer, superficial or in-situ cancer of the bladder or other cancer for which
- •the patient has been disease-free for five years.
- •Serious concomitant disease, or active infections.
- •History of autoimmune disease or organ allografts (or with active acute or
- •chronic infection, including HIV and viral hepatitis).
- •Serious intercurrent chronic or acute illness such as pulmonary disease
- •(asthma or COPD), cardiac disease (NYHA class III or IV), hepatic disease or
- •other illness considered by the study coordinator to constitute an unwarranted
- •high risk for investigational DC treatment.
- •Known allergy to shell fish (may contain keyhole limpet hemocyanin (KLH).
- •Pregnant or lactating women.
- •Inadequate vein access to perform leukapheresis.
- •Concomitant participation in another clinical trial (except participation in
- •a biobank study).
- •An organic brain syndrome or other significant psychiatric abnormality which
- •would compromise the ability to give informed consent, and preclude
- •participation in the full protocol and follow-up.
- •Absence of assurance of compliance with the protocol. Lack of availability
- •for follow-up assessment.
研究者
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