EUCTR2006-006962-41-DE进行中（未招募）1 期
Dendritic cells as autologous vaccine in patients with chronic myeloid leukemia - DC vaccination in CM
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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.Patients with bcr/abl-positive CML in stable cytogenetic / molekular remission after at least 18 months therapy with tyrosine kinase inhibitors. The following groups of patients will be included:
- •a) complete cytogenetic remission (CCyR), but stable detection of bcr/abl-transkript on qPCR (at least on two different time points over a period of at least 6 months). A stable molecular remission is assumed, if the difference between the qPCR values does not exceed a factor 5 (< 0,5log).
- •b) No CCyR, but qPCR for bcr/abl transcript < 10% (= MCyR) after at least 24 months on 2nd generation TKI therapy.
- •2.Treatment with a TKI inhibitor and an additional anti leukemic drug is no exclusion criterion.
- •3. Patients on treatment with a-interferone can only be included, if they have already achieved a MMR
- •4. Age 18-80 years
- •5. Performance status of 0 or 1 according to WHO index or Karnofsky index >70 %
- •6. Life expectancy > 18 months
- •7. Hematological function should be at least partially conserved (plts count >50.000/ µl, Hb > 8g/dl)
- •8. written informed consent
- •9. No breast feeding
- •10. if of chilbearing potential, negative pregnancy test (serum/urine ß-HCG) and willingness to use highly effective contraceptive methods (Pearl Index <1, e.g.: birth control pill, loop, hormone implant, transdermal hormone patch, a combination of two barrier methods [condome and vaginal diaphragm] sterilisation or sexual abstinence) for the study duration and thereafter as long as under treatment with antileukemic drugs
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Clinically relevant autoimmune disorders
- •2. Immunodeficiency syndromes
- •3. Known allergy to GM-CSF, TNF-a , IL-4 or KLH
- •4. Pregnancy (absence confirmed by serum/urine ß-HCG) or breast-feeding
- •5. Women of childbearing age without highly effective contraception
- •6. Active infectious disease requiring treatment
- •7. Continuous therapy with corticosteroids or other immunosuppressive drugs
- •8. Severe psychiatric disorders
- •9. Organ dysfunction:
- •a/ Thrombin Time / Partial Thromboplastin Time > 1,5 x upper normal limit
- •b/ creatinine > 2,0 mg/ml
- •c/ Bilirubin > 3,0 mg/ml, ALAT/ASAT > 3x upper normal limit
- •d/ pulmonary disfunction (dyspnea at rest or with minimal exertion)
- •e/clinically relevant coronary heart disease or ventricular arrhythmia, congestive heart failure > grade II NYHA
- •10. Persons who are detained officially or legally to an official institute
- •11. Subjects for whom there is concern about compliance with the protocol procedures
- •12. Present History of substance abuse (drug or alcohol) or any other factor (e.g., serious psychiatric condition) that could limit the subject’s ability to comply with study procedures
研究者
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