An international, multicentre, open-label study to evaluate the efficacy and safety of two different vaccination regimens of immunotherapy with allogeneic dendritic cells, DCP-001, in patients with acute myeloid leukemia that are in remission with persistent MRD. - ADVANCE II

Immunicum AB (voorheen DCprime bv)0 个研究点目标入组 1 人开始时间: 待定最近更新: 2024年7月22日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 1

研究概览入排标准研究者记录与标识符相似试验

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 64（—）

入选标准

•1. Confirmed diagnosis of AML according to WHO2016 criteria, including
•cytological, molecular and cytogenetic criteria (except acute promyelocytic
•leukemia/APL).
•2. In CR1 or CRi documented by bone marrow examination up to one month before
•vaccination; CR defined as less than 5% blasts in normo-cellular bone marrow,
•ANC >1*10E9/L, platelet count 100*E9/L, no evidence of extra-medullary disease.
•Patients in CRi (patients with <5% blasts but with incomplete blood count
•recovery) should have platelets >50 G/L.
•3. MRD as defined by multicolor flow cytometry (MFC) at a value of > 0.1% or
•detection of specific molecular abnormalities such as NPM1 mutation.
•4. Patients that are in CR1 or CRi. Patients not having undergone consolidation
•therapy must have been in CR1 or CRi for at least 1 month prior to enrolment. .
•Patients treated with hypomethylating agents must have been given at least two
•cycles and up to a maximum of nine cycles of hypomethylating agents.
•5. Expected to be willing and able to undergo all study procedures, including
•outpatient evaluations for clinical and immunological monitoring.
•6. Male or female > 18 years of age.
•7. Women of childbearing potential must be on anti-conceptive therapy, or using
•an intrauterine device, or use two (2) barrier contraceptive methods (one by
•each partner and at least one of the barrier methods must include spermicide
•(unless spermicide is not approved in the country or region), or underwent
•tubal ligation, or the partner was vasectomized, or is sexually abstinent.
•8. ECOG (WHO) performance status 0-2.
•9. Willing and able to provide written informed consent for participation in
•the study and for tissue sample biobanking..

排除标准

•1. APL (M3) type of AML.
•2. Patients who have undergone or are scheduled/eligible for allogeneic stem
•cell transplantation.
•3. History of previous allogeneic bone marrow or solid organ transplantation.
•4. Uncontrolled or serious infections
•5. Ongoing immunosuppressive therapy, other than short use of low dose
•steroids, i.e. equivalent to an average dose of <=10mg of prednisone/day.
•6. Chemotherapy and antineoplastic therapy within 28 days prior to the
•screening visit, with the exception of hypomethylating agents such as
•azacitidine and decitabine, or midostaurin for FLT3 mutations, or patients
•treated with IDH1/2 inhibitors in mIDH1/2.
•7. Current or past medical history of autoimmune disease.
•8. Inadequate liver function (AST and ALT > 3 x ULN, serum bilirubin >3x ULN).
•9. Other active Malignancies within the last 5 years, except for adequately
•treated carcinoma in situ of the cervix or squamous carcinoma of the skin or
•adequately controlled limited basal cell skin cancer.
•10. Pregnant or lactating females.
•11. Major surgical procedure (including open biopsy) within 28 days prior to
•the first study treatment, or anticipation of the need for major surgery during
•the course of the study treatment.
•12. Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm
•Hg) or clinically significant (i.e. active) cardiovascular disease.
•13. Evidence of any other medical conditions (such as psychiatric illness,
•physical examination or laboratory findings that may interfere with the planned
•treatment, affect patient compliance or place the patient at high risk from
•treatment-related complications.
•14. Known HIV, Hepatitis B or C infections.
•15. History of hypersensitivity to the investigational medicinal product or to
•any excipient present in the pharmaceutical form of the investigational
•medicinal product

研究者

发起方

Immunicum AB (voorheen DCprime bv)

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