EUCTR2015-001611-12-ES进行中（未招募）1 期
A Randomized Phase 2 Study of DACOGEN® (Decitabine) Plus JNJ-56022473 (Anti-CD123) Versus DACOGEN (Decitabine) Alone in Patients with AML who are not Candidates for Intensive Chemotherapy.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 326
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
- •- De novo or secondary acute myeloid leukemia (AML) according to WHO 2008 criteria
- •For Part A:
- •- Participants With AML: treatment naive or relapsed for whom experimental therapy is appropriate (as assessed by their treating physician)
- •For Part B:
- •- Previously untreated AML (except: emergency leukapheresis and/or hydroxyurea during the screening phase to control hyperleukocytosis); Of note: treatment with hydroxyurea has to be discontinued at least one day prior to start of study therapy
- •- Not eligible for standard intensive chemotherapy for induction and consolidation based on documented investigator assessment of disease- and patient characteristics as recorded in the electronic case report form (eCRF); these parameters include age, Eastern Cooperative Oncology Group (ECOG) performance status score, cytogenetic risk group, and comorbidities (cardiac, infectious, hepatic, diabetes-related, pulmonary, obesity-related, cerebrovascular accident-related, peptic-ulcer, and others)
- •- Not eligible for an allogeneic hematopoietic stem cell transplantation
- •- ECOG Performance Status score of 0, 1 or 2
- •- A woman must be either: Not of childbearing potential: postmenopausal (more than [>] 45 years of age with amenorrhea for at least 12 months; If, of childbearing potential must be practicing a highly effective method of birth control
- •- A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening
- •- A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control eg, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository for at least 3 months after last study treatment
- •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 6
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •- Acute promyelocytic leukemia with t(15;17), or its molecular equivalent (PML-RARalpha)
- •- For Part B only: Known leukemic involvement or clinical symptoms of leukemic involvement of the central nervous system
- •- In the case of AML from antecedent myelodysplastic syndrome (MDS), subjects who received prior treatment with a hypomethylating agent. For Part A, subjects with relapsed AML who received prior treatment with a hypomethylating agent
- •- For Part A only: Subjects who did not recover from all clinically significant toxicities (excluding alopecia and hematologic toxicities) of any previous surgery, radiotherapy, targeted therapy, or chemotherapy to less than or equal to Grade 1
- •- For Part A only: Subjects who did not recover from all clinically significant toxicities (excluding alopecia and hematologic toxicities) of any previous surgery, radiotherapy, targeted therapy, or chemotherapy to less than or equal to Grade 1
- •- Any active infection that is not responding to treatment
研究者
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