EUCTR2015-002892-30-IT进行中（未招募）1 期
An open-label, Phase I/II trial to determine the maximum tolerated doseand investigate safety, pharmacokinetics and efficacy of BI 836858 incombination with decitabine in patients with acute myeloid leukemia -
BOEHRINGER-INGELHEIM ITALIA S.P.A.0 个研究点目标入组 200 人开始时间: 2020年11月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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)Phase I Dose Escalation:
- •a.Male or female patients >/= 18 years of age with relapsed or
- •refractory AML
- •b.Male or female patients >/= 65 years of age with previously untreated
- •AML ineligible for receiving standard intensive therapy
- •Phase I Extension and Phase II:
- •Male or female patients >/= 65 years of age with previously untreated
- •AML ineligible for receiving standard intensive therapy
- •2)Histologically or cytologically confirmed AML according to the WHO
- •classification
- •3)Patients must be eligible for treatment with decitabine
- •4)Eastern co-operative oncology group (ECOG) performance score at screening
- •5)Signed and dated written informed consent (including consent for biomarker and
- •genetic testing; refer to Section 8.1) by the start date of the Screening Visit in
- •accordance with GCP and local legislation.
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 145
排除标准
- •1) Acute promyelocytic leukemia (APL, French-American-British (FAB)
- •subtype M3), according to WHO classification
- •2) Patients who are candidates for allogeneic stem cell transplantation.
- •3) Active chronic graft versus host disease requiring immunosuppressive
- •4) Prior treatment with a hypomethylating agent (this also includes prior
- •MDS treatment with decitabine or azazitidine)
- •5) Prior treatment with Cluster of differentiation 33 (CD33) antibody
研究者
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