EUCTR2011-004144-22-BE进行中（未招募）不适用
A Phase I/II study to assess the safety and immunogenicity of WT1-A10 + AS01B Antigen-Specific Cancer Immunotherapeutic (ASCI) combined with infusions of ex vivo regulatory T cells depleted T lymphocytes in in vivo regulatory T cells depleted patients as post-consolidation therapy for adult patients with WT1-positive Acute Myeloid Leukemia (AML) in CR1 (for high risk patients) or in CR2 or CR3 who are not eligible for allogeneic stem cell transplantation (SCT)
Institut Jules Bordet - Université Libre de Bruxelles0 个研究点开始时间: 2011年9月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •The following criteria are to be checked at the time of study entry. Patients may only be included in the study if all of the following criteria are met:
- •1. The patient has cytologically proven AML, as defined by the WHO classification. The leukemia is a de novo or a secondary leukemia.
- •2. The patient received the following therapy according to the institution’s standard of care:
- •For patients = 60 years old, at least two cycles of intensive chemotherapy (induction and consolidation)
- •For patients > 60 years old, at least one induction chemotherapy. Any patients with severe co-morbidity for which consolidation is unacceptable, can receive only one induction therapy.
- •3. The patient is in complete morphologic remission, as detailed in Appendix G
- •a)AML patients in first complete remission (CR1) who are not eligible for allo-HSCT following the institution’s standard of care, except the favourable genetic group subset as defined in Table 1 below which is excluded from this study.
- •According to the EBMT treatment consensus: favourable risk group AML patients should not be transplanted upfront, whilst high and intermediate-II risk group patients should be transplanted as first treatment option (The EBMT handbook 5th edition, 2008). The benefit of transplant for the intermediate group-I is still an open question and a center decision.
- •b)All AML patients in second or third complete morphological remission (CR2 or CR3) according to response criteria who are not eligible for allo-SCT.
- •4. The patient's blasts cells show over-expression of WT1 transcripts, detected in peripheral blood by qRT-PCR at diagnosis or in first relapse.
- •Note: WT1 expression analysis will be done using peripheral blood obtained before chemotherapy.
- •5. Written informed consent has been obtained prior to the performance of any protocol-specific procedure.
- •6. The patient is = 18 years of age at the time of signing of the ICF.
- •7. ECOG performance status of 0, 1, or 2 at the time of enrolment.
- •8. Adequate hepatic and renal function defined as:
- •- Serum bilirubin < 1.5 times the Upper Limit of Normal (ULN).
- •- Serum alanine aminotransferase ALAT < 2.5 times the ULN.
- •- Calculated creatinine clearance > 40 mL/min.
- •9. If the patient is female, then she must be of non-childbearing potential, i.e., have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to treatment administration, have a negative pregnancy test, and continue such precautions for two months after completion of the treatment administration series.
- •10. Under the investigator criteria, the patient is able to comply with the protocol requirements during the duration of the study.
- •11. In the investigator's opinion and in compliance with the Institution hematology guidance, the patient should not be eligible for an approved standard of care such as induction with chemotherapy or allo-HSCT.
- •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 7
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •The following criteria should be checked at the time of study entry. If any are met, then the patient must not be included in the study:
- •1. The patient is in morphologic leukemia-free state or in morphologic complete remission but with incomplete blood count recovery as defined by IWG Response Criteria (Appendix G)
- •2. The patient is in CR1 and is in the category of low-risk for relapse patients, i.e. belong to the favourable genetic group subset (as described in table 1).
- •3. The patient was diagnosed with leukemic central nervous system (CNS) disease (E.g. before chemotherapy) or presents neurological symptoms at baseline suggestive of a CNS involvement.
- •4. The patient has received, is receiving (or is due to receive) allogeneic HSCT.
- •5. The patient has concomitant malignancies, except effectively treated malignancy that is considered by the investigator highly likely to have been cured.
- •6. The patient is known to be human immunodeficiency virus positive.
- •7. The patient has autoimmune disease such as, but not limited to, multiple sclerosis, lupus, rheumatoid arthritis and inflammatory bowel disease.
- •8. The patient has a history of allergic reactions likely to be exacerbated by any component of the study investigational product.
- •9. The patient has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
- •10. The patient has congestive heart failure, symptomatic coronary artery disease, or previous myocardial infarction.
- •11. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures.
- •12. The patient has received any investigational or non-registered medicinal product other than the study medication within 30 days preceding the first dose of study medication, or plans to receive such a drug during the study period.
- •13. The patient requires concomitant treatment with systemic corticosteroids or any immunosuppressive agents. The use of inhaled corticosteroids or topical steroids is permitted.
- •14. The patient has an active infection and/or is receiving antibiotics. Enrolment will be allowed 48h00 after the end of the treatment.
- •15. For female patients: the patient is pregnant or lactating.
研究者
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