EUCTR2015-004058-17-SE进行中（未招募）1 期
An open-label, randomised, Phase II study to investigate the efficacy andsafety of ALECSAT treatment as an add-on therapy to radiotherapy andtemozolomide in patients with newly diagnosed glioblastoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- CytoVac A/S
- 入组人数
- 60
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. Male or female patients, aged between 18 and 70.
- •2. Histologically confirmed, newly diagnosed glioblastoma, including
- •gliosarcoma.
- •3. Eligible for combined radiotherapy and TMZ treatment. (Stupp
- •4. Patients with complete or partial tumour resection. For patients
- •with limited tumour volume, biopsy is acceptable.
- •5. WHO Performance status 0-2.
- •6. Body weight 40 = kg (males), 50 = kg (females).
- •7. Able and willing to provide written informed consent and comply
- •with the study protocol and procedures.
- •8. Women of child-bearing potential must have a negative pregnancy
- •test at screening and agree to use acceptable methods of
- •contraception during the study. A highly effective method of birth
- •control is defined as those which result in a low failure rate (i.e.
- •less than 1% per year) when used consistently and correctly such
- •as implants, injectables, combined oral, intravaginal and
- •transdermal contraceptives, some intrauterine devices (IUDs),
- •intrauterine system (IUS), bilateral tubal occlusion, sexual
- •abstinence or vasectomised partner. True abstinence should be
- •consistent with the preferred and usual lifestyle of the patient.
- •Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-
- •ovulation methods) and withdrawal are not acceptable methods of
- •contraception.
- •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 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Prior treatment for brain tumours at study entry.
- •2. Prior treatment with temozolomide at study entry.
- •3. Females who are pregnant, planning to become pregnant or
- •breastfeeding.
- •4. Positive tests for anti- human immunodeficiency virus (HIV)-1/2;
- •HBsAg, anti HBc, anti-HCV or being positive in a Treponema
- •Pallidum test (syphilis).
- •5. Patients who may have been exposed to high risk contagious virus
- •within a reasonable time prior to enrolment should be excluded,
- •unless the patient has been tested negative. e.g. by travelling in
- •areas of the world with known high risk of infection or known
- •epidemics, (in particular but not limited to West e virus (in
- •season), Dengue fever, Zika or Ebola when outbreaks are
- •recognized)
- •6. Patients from high incidence areas for Human T-Lymphotropic
- •Virus (HTLV-1) virus or who has a parent or spouse from a high
- •incidence area must be excluded unless tested negative for HTLV-1
- •7. Known allergy to study medication.
- •8. Any condition or illness that, in the opinion of the Investigator,
- •would compromise patient safety or interfere with the evaluation
- •of the safety of the investigational drug.
- •9. Any concurrent illness that may worsen or cause complications in
- •connection with blood donation, for example uncontrolled
- •epilepsy, cardiovascular, cerebrovascular or respiratory disease.
- •10. Use of immunosuppressant drugs with the exception of steroids.
- •11. Blood transfusion within 48 hours prior to the donation of blood
- •for ALECSAT production.
- •12. Low haemoglobin count, in the opinion of the Investigator.
- •13. Lymphocyte count <0.3 x 10E9 /litre.
- •14. Receiving any other experimental treatment, including
- •compassionate use programs and other interventional clinical
- •studies for glioblastoma, within 30 days prior to inclusion, at the
- •moment of inclusion or during active treatment within the
- •assigned group.
- •15. TMZ contraindication.
研究者
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